Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-30 @ 4:44 PM
Study NCT ID:
NCT05085834
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2019-07-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zinc Effect on Inflammation and Cardiovascular Risk in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C030691', 'term': 'gluconic acid'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Grace.McComsey@uhhospitals.org', 'phone': '216-368-3731', 'title': 'Grace McComsey', 'organization': 'University Hospitals Cleveland Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Zinc Gluconate', 'description': 'Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.\n\nZinc Gluconate: Two 45 mg capsules once daily', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 48, 'seriousNumAtRisk': 63, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.\n\nPlacebo: Two placebo capsules once daily', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 27, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal adhesions with intestinal torsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abcess post root canal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left groin hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in right hip and Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral Neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scrotal Abcess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening of depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High ALT and/or AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Creatine Kinase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 17}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Hemoglobin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Phosphorus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Sodium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Sodium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Alkaline Phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Bilirubin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Glucose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High LDL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Triglycerides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'High Uric Acid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'Death occurred secondary to drug overdose not related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'categories': [{'measurements': [{'value': '8.60', 'groupId': 'OG000', 'lowerLimit': '1.65', 'upperLimit': '20.00'}, {'value': '33.50', 'groupId': 'OG001', 'lowerLimit': '14.00', 'upperLimit': '62.70'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.43', 'ciUpperLimit': '0.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'effect of Zinc supplementation on ln(Zinc, μg/dL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 weeks', 'description': 'Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency', 'unitOfMeasure': 'absolute change (μg/dL)', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'PRIMARY', 'title': 'Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'title': 'hsCRP (ng/mL)', 'categories': [{'measurements': [{'value': '-22.86', 'groupId': 'OG000', 'lowerLimit': '-689.27', 'upperLimit': '1744.48'}, {'value': '1.33', 'groupId': 'OG001', 'lowerLimit': '-602.56', 'upperLimit': '1174.87'}]}]}, {'title': 'sCD14 (ng/mL)', 'categories': [{'measurements': [{'value': '101.71', 'groupId': 'OG000', 'lowerLimit': '-90.50', 'upperLimit': '243.20'}, {'value': '-56.31', 'groupId': 'OG001', 'lowerLimit': '-263.24', 'upperLimit': '134.19'}]}]}, {'title': 'sCD163 (ng/mL)', 'categories': [{'measurements': [{'value': '-50.11', 'groupId': 'OG000', 'lowerLimit': '-153.06', 'upperLimit': '89.80'}, {'value': '43.69', 'groupId': 'OG001', 'lowerLimit': '-102.27', 'upperLimit': '126.91'}]}]}, {'title': 'D-dimer (ng/mL)', 'categories': [{'measurements': [{'value': '-149.05', 'groupId': 'OG000', 'lowerLimit': '-294.46', 'upperLimit': '58.72'}, {'value': '-45.85', 'groupId': 'OG001', 'lowerLimit': '-295.57', 'upperLimit': '142.43'}]}]}, {'title': 'VCAM (ng/mL)', 'categories': [{'measurements': [{'value': '66.69', 'groupId': 'OG000', 'lowerLimit': '-2.65', 'upperLimit': '187.38'}, {'value': '49.53', 'groupId': 'OG001', 'lowerLimit': '-55.61', 'upperLimit': '170.15'}]}]}, {'title': 'ICAM (ng/mL)', 'categories': [{'measurements': [{'value': '-2.03', 'groupId': 'OG000', 'lowerLimit': '-28.37', 'upperLimit': '22.30'}, {'value': '2.35', 'groupId': 'OG001', 'lowerLimit': '-29.19', 'upperLimit': '42.46'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.002', 'ciLowerLimit': '-0.57', 'ciUpperLimit': '0.57', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.29', 'groupDescription': 'effect of Zinc supplementation on ln(hsCRP ng/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.01', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': 'effect of Zinc supplementation on ln(sCD14, ng/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.77', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'effect of Zinc supplementation on ln(sCD163, ng/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.50', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'effect of Zinc supplementation on ln(D-dimer, ng/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.10', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'effect of Zinc supplementation on ln(VCAM, ng/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.41', 'ciLowerLimit': '-39.16', 'ciUpperLimit': '39.98', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '20.19', 'groupDescription': 'effect of Zinc supplementation on ln(ICAM, ng/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of inflammation and immune activation by measuring monocyte activation soluble markers CD14 (sCD14), and soluble CD163 (sCD163), high sensitivity C reactive protein (hsCRP), D-dimer, vascular cell adhesion molecule-1 (VCAM), and intercellular adhesion molecule-1 (I-CAM)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'PRIMARY', 'title': 'Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'title': 'sTNF-RI (pg/mL)', 'categories': [{'measurements': [{'value': '-25.08', 'groupId': 'OG000', 'lowerLimit': '-209.51', 'upperLimit': '186.66'}, {'value': '1.27', 'groupId': 'OG001', 'lowerLimit': '-236.80', 'upperLimit': '168.27'}]}]}, {'title': 'sTNF-RII (pg/mL)', 'categories': [{'measurements': [{'value': '-121.65', 'groupId': 'OG000', 'lowerLimit': '-457.93', 'upperLimit': '467.29'}, {'value': '99.33', 'groupId': 'OG001', 'lowerLimit': '-484.31', 'upperLimit': '477.72'}]}]}, {'title': 'IL-6 (pg/mL)', 'categories': [{'measurements': [{'value': '-0.47', 'groupId': 'OG000', 'lowerLimit': '-0.85', 'upperLimit': '0.61'}, {'value': '-0.02', 'groupId': 'OG001', 'lowerLimit': '-0.88', 'upperLimit': '0.72'}]}]}, {'title': 'IP-10 (pg/mL)', 'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '-44.28', 'upperLimit': '29.08'}, {'value': '-9.99', 'groupId': 'OG001', 'lowerLimit': '-31.65', 'upperLimit': '20.27'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '0.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'groupDescription': 'effect of Zinc supplementation on ln(sTNF-RI , pg/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.004', 'ciLowerLimit': '-0.13', 'ciUpperLimit': '0.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'effect of Zinc supplementation on ln(sTNF-RII, pg/m)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.30', 'ciUpperLimit': '0.43', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.19', 'groupDescription': 'effect of Zinc supplementation on ln(IL-6, pg/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'groupDescription': 'effect of Zinc supplementation on ln(IP-10, pg/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of inflammation and immune activation by measuring soluble tumor necrosis alpha receptor I and II (sTNFR-I and II), Interleukin-6 (IL-6), and interferon-gamma-inducible protein of 10 kDa (IP-10).', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'PRIMARY', 'title': 'Effect of Zinc on oxLDL in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'categories': [{'measurements': [{'value': '20833.33', 'groupId': 'OG000', 'lowerLimit': '2397.72', 'upperLimit': '61644.46'}, {'value': '8639.79', 'groupId': 'OG001', 'lowerLimit': '-1716.35', 'upperLimit': '43693.14'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1819.18', 'ciLowerLimit': '-14899.37', 'ciUpperLimit': '18537.74', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '8530.03', 'groupDescription': 'effect of Zinc supplementation on ln(OxLDL, U/L)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks', 'unitOfMeasure': 'U/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'title': 'Non-HDL cholesterol (mg/dL)', 'categories': [{'measurements': [{'value': '3.10', 'groupId': 'OG000', 'lowerLimit': '-28.20', 'upperLimit': '26.50'}, {'value': '1.35', 'groupId': 'OG001', 'lowerLimit': '-12.30', 'upperLimit': '10.85'}]}]}, {'title': 'HDL (mg/dL)', 'categories': [{'measurements': [{'value': '-1.70', 'groupId': 'OG000', 'lowerLimit': '-4.60', 'upperLimit': '1.40'}, {'value': '-2.45', 'groupId': 'OG001', 'lowerLimit': '-8.45', 'upperLimit': '1.25'}]}]}, {'title': 'LDL (mg/dL)', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '-28.00', 'upperLimit': '16.00'}, {'value': '-1.50', 'groupId': 'OG001', 'lowerLimit': '-19.50', 'upperLimit': '11.50'}]}]}, {'title': 'VLDL (mg/dL)', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-6.00', 'upperLimit': '3.50'}, {'value': '2.00', 'groupId': 'OG001', 'lowerLimit': '-2.00', 'upperLimit': '6.00'}]}]}, {'title': 'Cholesterol (mg/dL)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-25.00', 'upperLimit': '27.00'}, {'value': '-3.50', 'groupId': 'OG001', 'lowerLimit': '-23.50', 'upperLimit': '12.00'}]}]}, {'title': 'Triglycerides (mg/dL)', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '-29.00', 'upperLimit': '12.00'}, {'value': '7.00', 'groupId': 'OG001', 'lowerLimit': '-12.50', 'upperLimit': '34.50'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'effect of Zinc supplementation on ln(Non-HDL Cholesterol (mg/dL))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.04', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.06', 'groupDescription': 'effect of Zinc supplementation on ln(HDL (mg/dL))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.19', 'ciUpperLimit': '0.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'groupDescription': 'effect of Zinc supplementation on ln(LDL (mg/dL))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'effect of Zinc supplementation on ln(VLDL (mg/dL))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.09', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.05', 'groupDescription': 'effect of Zinc supplementation on ln(Cholesterol (mg/dl))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.12', 'groupDescription': 'effect of Zinc supplementation on ln(Triglycerides (mg/dL))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.44', 'ciLowerLimit': '-1.36', 'ciUpperLimit': '0.48', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'groupDescription': 'effect of Zinc supplementation on Metabolic Syndrome', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring Non-HDL cholesterol, high-density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), Cholesterol, Cholesterol - HDL Ratio, and Triglycerides.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'groupId': 'OG000', 'lowerLimit': '-0.20', 'upperLimit': '0.40'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.10', 'upperLimit': '0.45'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.20', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'effect of Zinc supplementation on ln(Chol:HDL Ratio)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '-0.52', 'upperLimit': '1.16'}, {'value': '0.10', 'groupId': 'OG001', 'lowerLimit': '-0.58', 'upperLimit': '0.95'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-4.29', 'ciUpperLimit': '3.60', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.01', 'groupDescription': 'effect of Zinc supplementation on BMI (kg/m2)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2)', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '-2.53', 'upperLimit': '2.50'}, {'value': '1.67', 'groupId': 'OG001', 'lowerLimit': '-2.67', 'upperLimit': '3.00'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'groupDescription': 'effect of Zinc supplementation on ln(Waist-umbilicus (cm))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm)', 'unitOfMeasure': 'cm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'groupId': 'OG000', 'lowerLimit': '-3.50', 'upperLimit': '7.60'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-4.00', 'upperLimit': '4.40'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.99', 'ciLowerLimit': '-26.97', 'ciUpperLimit': '20.99', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.23', 'groupDescription': 'effect of Zinc supplementation on Weight (lbs)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring body weight (lbs)', 'unitOfMeasure': 'lbs', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'title': 'Systolic Blood Pressure (mmHg)', 'categories': [{'measurements': [{'value': '6.00', 'groupId': 'OG000', 'lowerLimit': '-4.00', 'upperLimit': '12.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-9.00', 'upperLimit': '9.00'}]}]}, {'title': 'Diastolic Blood Pressure (mmHg)', 'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '-5.00', 'upperLimit': '6.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-5.00', 'upperLimit': '5.00'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.02', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.03', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.03', 'groupDescription': 'effect of Zinc supplementation on ln(Systolic blood pressure (mmHg))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.68', 'ciLowerLimit': '-5.71', 'ciUpperLimit': '2.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.06', 'groupDescription': 'effect of Zinc supplementation on Diastolic blood pressure (mmHg)', 'statisticalMethod': 'linear combination of coeff', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'categories': [{'measurements': [{'value': '0.40', 'groupId': 'OG000', 'lowerLimit': '-1.10', 'upperLimit': '2.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '-1.35', 'upperLimit': '1.55'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.17', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'groupDescription': 'effect of Zinc supplementation on ln(10 year ASCVD (%))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation were measured by measuring 10-year atherosclerotic cardiovascular disease (ASCVD), which is the probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years with higher scores indicating worse outcome', 'unitOfMeasure': 'percentage of 10-year ASCVD score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'title': 'Reactive Hyperemic Index', 'categories': [{'measurements': [{'value': '-0.34', 'groupId': 'OG000', 'lowerLimit': '-0.77', 'upperLimit': '0.16'}, {'value': '-0.18', 'groupId': 'OG001', 'lowerLimit': '-0.60', 'upperLimit': '0.23'}]}]}, {'title': 'Augmentation Index', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-8.00', 'upperLimit': '5.50'}, {'value': '-1.00', 'groupId': 'OG001', 'lowerLimit': '-7.00', 'upperLimit': '6.00'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.17', 'ciUpperLimit': '0.10', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.07', 'groupDescription': 'effect of Zinc supplementation on Reactive Hyperemic Index', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.81', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.59', 'ciLowerLimit': '-4.19', 'ciUpperLimit': '5.36', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.43', 'groupDescription': 'effect of Zinc supplementation on Augmentation Index', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of endothelial function including the Reactive Hyperemic Index and Augmentation Index Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia.\n\nA Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to baseline in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal, while a value of 1.67 or lower is considered abnormal. Higher values indicate better endothelial function.', 'unitOfMeasure': '(ratio) absolute change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'title': 'IFAB (pg/mL)', 'categories': [{'measurements': [{'value': '100.82', 'groupId': 'OG000', 'lowerLimit': '-747', 'upperLimit': '953.32'}, {'value': '58.89', 'groupId': 'OG001', 'lowerLimit': '-1049.29', 'upperLimit': '654.96'}]}]}, {'title': 'BDG (pg/mL)', 'categories': [{'measurements': [{'value': '-28.19', 'groupId': 'OG000', 'lowerLimit': '-100.43', 'upperLimit': '4.02'}, {'value': '8.36', 'groupId': 'OG001', 'lowerLimit': '-63.26', 'upperLimit': '76.12'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '0.30', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'effect of Zinc supplementation on ln(IFAB (pg/mL))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.18', 'ciLowerLimit': '-0.12', 'ciUpperLimit': '0.47', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'groupDescription': 'effect of Zinc supplementation on ln(BDG (pg/mL))', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of Gut Integrity Markers including: intestinal fatty acid-binding protein (IFAB) and (1,3)-β-d-glucan (BDG)', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}, {'type': 'SECONDARY', 'title': 'Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'participants assigned to the placebo group'}, {'id': 'OG001', 'title': 'Zinc 90 mg', 'description': 'participants assigned to the Zinc group'}], 'classes': [{'title': 'LBP (μg/mL)', 'categories': [{'measurements': [{'value': '0.47', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '8.35'}, {'value': '0.72', 'groupId': 'OG001', 'lowerLimit': '-4.52', 'upperLimit': '6.9'}]}]}, {'title': 'Zonulin (μg/mL)', 'categories': [{'measurements': [{'value': '78.2', 'groupId': 'OG000', 'lowerLimit': '-138', 'upperLimit': '506.86'}, {'value': '270.54', 'groupId': 'OG001', 'lowerLimit': '59.36', 'upperLimit': '600.45'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.32', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.14', 'groupDescription': 'effect of Zinc supplementation on ln(LBP (ng/mL))', 'statisticalMethod': 'v', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'paramType': 'β coefficient', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '0.34', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.13', 'groupDescription': 'effect of Zinc supplementation on ln(Zonulin (ng/mL)', 'statisticalMethod': 'linear combination of coefficients', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Generalized estimating equations were used while adjusting for age and sex, and examining interactions between time and treatment. Combining linear coefficients in the equation while accounting for the multiplicative effects of treatment and time were considered to assess the true effect size of zinc supplementation on biomarkers.'}], 'paramType': 'MEDIAN', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin.', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'absolute changes for outcome measures over 24 weeks for each group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zinc Gluconate', 'description': 'Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.\n\nZinc Gluconate: Two 45 mg capsules once daily'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.\n\nPlacebo: Two placebo capsules once daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Inability to swallow the pill', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zinc Gluconate', 'description': 'Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.\n\nZinc Gluconate: Two 45 mg capsules once daily'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.\n\nPlacebo: Two placebo capsules once daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.42', 'groupId': 'BG000', 'lowerLimit': '38.92', 'upperLimit': '60.55'}, {'value': '53.29', 'groupId': 'BG001', 'lowerLimit': '45.31', 'upperLimit': '58.90'}, {'value': '52.42', 'groupId': 'BG002', 'lowerLimit': '40.34', 'upperLimit': '60.12'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'alcohol (current)', 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'smokers (current)', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CD4+ T-Cell Count', 'classes': [{'categories': [{'measurements': [{'value': '747.00', 'groupId': 'BG000', 'lowerLimit': '529.00', 'upperLimit': '1024.00'}, {'value': '668.00', 'groupId': 'BG001', 'lowerLimit': '507.00', 'upperLimit': '775.00'}, {'value': '722.00', 'groupId': 'BG002', 'lowerLimit': '526.00', 'upperLimit': '973.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cells/mm³', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV RNA (<20 copies)', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anti-Retroviral Treatment Duration', 'classes': [{'categories': [{'measurements': [{'value': '178.76', 'groupId': 'BG000', 'lowerLimit': '107.20', 'upperLimit': '232.51'}, {'value': '167.86', 'groupId': 'BG001', 'lowerLimit': '115.14', 'upperLimit': '239.51'}, {'value': '171.86', 'groupId': 'BG002', 'lowerLimit': '108.22', 'upperLimit': '236.36'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Months', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Protease Inhibitor use', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index BMI', 'classes': [{'categories': [{'measurements': [{'value': '28.34', 'groupId': 'BG000', 'lowerLimit': '24.80', 'upperLimit': '32.70'}, {'value': '27.45', 'groupId': 'BG001', 'lowerLimit': '23.23', 'upperLimit': '32.40'}, {'value': '28.08', 'groupId': 'BG002', 'lowerLimit': '24.62', 'upperLimit': '32.70'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Waist circumference', 'classes': [{'categories': [{'measurements': [{'value': '96.67', 'groupId': 'BG000', 'lowerLimit': '89.83', 'upperLimit': '106.33'}, {'value': '97.83', 'groupId': 'BG001', 'lowerLimit': '87.50', 'upperLimit': '106.42'}, {'value': '97.00', 'groupId': 'BG002', 'lowerLimit': '89.17', 'upperLimit': '106.33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000', 'lowerLimit': '117', 'upperLimit': '139'}, {'value': '129', 'groupId': 'BG001', 'lowerLimit': '118.5', 'upperLimit': '141'}, {'value': '126', 'groupId': 'BG002', 'lowerLimit': '117', 'upperLimit': '141'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000', 'lowerLimit': '75', 'upperLimit': '85'}, {'value': '82', 'groupId': 'BG001', 'lowerLimit': '77', 'upperLimit': '88.5'}, {'value': '81', 'groupId': 'BG002', 'lowerLimit': '75', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Non-High Density Lipoprotein non-HDL cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '115.30', 'groupId': 'BG000', 'lowerLimit': '98', 'upperLimit': '147.6'}, {'value': '115.50', 'groupId': 'BG001', 'lowerLimit': '93.90', 'upperLimit': '166.25'}, {'value': '115.30', 'groupId': 'BG002', 'lowerLimit': '95.7', 'upperLimit': '149.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '(mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'High Density Lipoprotein', 'classes': [{'categories': [{'measurements': [{'value': '45.40', 'groupId': 'BG000', 'lowerLimit': '39.80', 'upperLimit': '60.80'}, {'value': '48.15', 'groupId': 'BG001', 'lowerLimit': '41.30', 'upperLimit': '62.70'}, {'value': '47.00', 'groupId': 'BG002', 'lowerLimit': '39.90', 'upperLimit': '61.10'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Low Density Lipoprotein LDL', 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000', 'lowerLimit': '74', 'upperLimit': '114'}, {'value': '89', 'groupId': 'BG001', 'lowerLimit': '66.5', 'upperLimit': '127.5'}, {'value': '96', 'groupId': 'BG002', 'lowerLimit': '71', 'upperLimit': '118'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Very Low Density Lipoprotein VLDL', 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000', 'lowerLimit': '15', 'upperLimit': '29'}, {'value': '20', 'groupId': 'BG001', 'lowerLimit': '15', 'upperLimit': '27'}, {'value': '21', 'groupId': 'BG002', 'lowerLimit': '15', 'upperLimit': '28.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000', 'lowerLimit': '144', 'upperLimit': '192'}, {'value': '165.5', 'groupId': 'BG001', 'lowerLimit': '147.5', 'upperLimit': '213.5'}, {'value': '169', 'groupId': 'BG002', 'lowerLimit': '144', 'upperLimit': '202'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'cholesterol/ high Density Lipoprotein Ratio', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '2.8', 'upperLimit': '4.4'}, {'value': '3.2', 'groupId': 'BG001', 'lowerLimit': '2.55', 'upperLimit': '4.85'}, {'value': '3.4', 'groupId': 'BG002', 'lowerLimit': '2.7', 'upperLimit': '4.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000', 'lowerLimit': '71', 'upperLimit': '146'}, {'value': '103', 'groupId': 'BG001', 'lowerLimit': '76.5', 'upperLimit': '136'}, {'value': '105', 'groupId': 'BG002', 'lowerLimit': '74', 'upperLimit': '146'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Insulin', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000', 'lowerLimit': '6', 'upperLimit': '17'}, {'value': '11.5', 'groupId': 'BG001', 'lowerLimit': '6.5', 'upperLimit': '18.5'}, {'value': '10.5', 'groupId': 'BG002', 'lowerLimit': '6', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mIU/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'atherosclerotic cardiovascular risk 10 year ASCVD', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'groupId': 'BG000', 'lowerLimit': '2.7', 'upperLimit': '11.1'}, {'value': '6.7', 'groupId': 'BG001', 'lowerLimit': '3.85', 'upperLimit': '12.5'}, {'value': '6.5', 'groupId': 'BG002', 'lowerLimit': '2.9', 'upperLimit': '11.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years.', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Presence of metabolic syndrome', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Endothelial Function: Reactive Hyperemic Index', 'classes': [{'categories': [{'measurements': [{'value': '1.91', 'groupId': 'BG000', 'lowerLimit': '1.6', 'upperLimit': '2.21'}, {'value': '1.89', 'groupId': 'BG001', 'lowerLimit': '1.62', 'upperLimit': '2.04'}, {'value': '1.9', 'groupId': 'BG002', 'lowerLimit': '1.6', 'upperLimit': '2.19'}]}]}], 'paramType': 'MEDIAN', 'description': 'Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia.\n\nA Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to the pulse wave amplitude (PWA) before the occlusion of the artery, in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal. Higher values indicate better endothelial function.', 'unitOfMeasure': 'ratio', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Endothelial Function: Augmentation Index', 'classes': [{'categories': [{'measurements': [{'value': '7.5', 'groupId': 'BG000', 'lowerLimit': '-2', 'upperLimit': '14'}, {'value': '11', 'groupId': 'BG001', 'lowerLimit': '4', 'upperLimit': '16'}, {'value': '10', 'groupId': 'BG002', 'lowerLimit': '-1', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'hsCRP', 'classes': [{'categories': [{'measurements': [{'value': '2240.00', 'groupId': 'BG000', 'lowerLimit': '1075.40', 'upperLimit': '7930.31'}, {'value': '1998.85', 'groupId': 'BG001', 'lowerLimit': '967.08', 'upperLimit': '6778.08'}, {'value': '2202.14', 'groupId': 'BG002', 'lowerLimit': '993.51', 'upperLimit': '7795.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 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'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Zinc level', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '72.2'}, {'value': '69', 'groupId': 'BG001', 'lowerLimit': '61.2', 'upperLimit': '73'}, {'value': '69.8', 'groupId': 'BG002', 'lowerLimit': '64.3', 'upperLimit': '73'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-19', 'size': 1974376, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-30T14:23', 'hasProtocol': True}, {'date': '2024-12-21', 'size': 815944, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-19T12:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients, study staff, and the study statistician will be blinded to treatment allocation (zinc gluconate or placebo capsules). The research staff as well as the principle investigator will remain blinded to treatment assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a double-blind randomized placebo-controlled trial 2:1 Patients will be given zinc gluconate capsules at a dose of 90 mg elemental zinc daily or matching placebo for 24 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2019-07-02', 'resultsFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2021-10-07', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-11', 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Zinc Supplementation on Zinc Levels at 24 Weeks in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 weeks', 'description': 'Changes in zinc levels after zinc supplementation in HIV-infected subjects with zinc deficiency'}, {'measure': 'Effect of Zinc Supplementation on Inflammation and Immune Activation in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of inflammation and immune activation by measuring monocyte activation soluble markers CD14 (sCD14), and soluble CD163 (sCD163), high sensitivity C reactive protein (hsCRP), D-dimer, vascular cell adhesion molecule-1 (VCAM), and intercellular adhesion molecule-1 (I-CAM)'}, {'measure': 'Effect of Zinc Supplementation on Inflammation in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of inflammation and immune activation by measuring soluble tumor necrosis alpha receptor I and II (sTNFR-I and II), Interleukin-6 (IL-6), and interferon-gamma-inducible protein of 10 kDa (IP-10).'}, {'measure': 'Effect of Zinc on oxLDL in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in oxidized low density lipoprotein (OxLDL) (U/L) over 24 weeks'}], 'secondaryOutcomes': [{'measure': 'Effect of Zinc Supplementation on Metabolic Markers at 24 Weeks in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring Non-HDL cholesterol, high-density lipoprotein (HDL), low density lipoprotein (LDL), very low density lipoprotein (VLDL), Cholesterol, Cholesterol - HDL Ratio, and Triglycerides.'}, {'measure': 'Effect of Zinc Supplementation on Cholesterol - HDL Ratio at 24 Weeks in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation for 24 weeks by measuring the Cholesterol - HDL Ratio'}, {'measure': 'the Effect of Zinc Supplementation on BMI at 24 Weeks in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring the body mass index (BMI) (kg/m2)'}, {'measure': 'Effect of Zinc on the Waist-umbilicus at 24 Weeks in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring Waist-umbilicus (cm)'}, {'measure': 'Effect of Zinc Supplementation on Weight at 24 Weeks in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring body weight (lbs)'}, {'measure': 'Effect of Zinc Supplementation on Blood Pressure at 24 Weeks in HIV-', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation by measuring Systolic Blood Pressure and Diastolic Blood Pressure (mmHg)'}, {'measure': 'Effect of Zinc Supplementation on 10 Year Atherosclerotic Cardiovascular Disease at 24 Weeks in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in metabolic markers after zinc supplementation were measured by measuring 10-year atherosclerotic cardiovascular disease (ASCVD), which is the probability (%) that an individual will have a first major ASCVD event (like a heart attack or stroke) within the next 10 years with higher scores indicating worse outcome'}, {'measure': 'Effect of Zinc Supplementation on Endothelial Function in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of endothelial function including the Reactive Hyperemic Index and Augmentation Index Endothelial function was assessed noninvasively using RH-PAT (EndoPAT 2000) with finger probes and brachial occlusion-induced hyperemia.\n\nA Reactive Hyperemia Index (RHI) was calculated from the change in pulse wave amplitude (PWA) relative to baseline in the occluded arm, corrected for corresponding changes in the contralateral, non-occluded arm to minimize the influence of non-endothelial-dependent systemic effects. An RHI value greater than 1.67 is considered normal, while a value of 1.67 or lower is considered abnormal. Higher values indicate better endothelial function.'}, {'measure': 'Effect of Zinc Supplementation on IFAB and BDG in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of Gut Integrity Markers including: intestinal fatty acid-binding protein (IFAB) and (1,3)-β-d-glucan (BDG)'}, {'measure': 'Effect of Zinc Supplementation on LBP and Zonuline in HIV-infected Subjects', 'timeFrame': 'between baseline and 24 Weeks', 'description': 'Changes in markers of Gut Integrity Markers including: lipopolysaccharide-binding protein (LBP) and Zonulin.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Zinc', 'inflammation', 'Cardiovascular Diseases risk'], 'conditions': ['Inflammation', 'Cardiovascular Diseases', 'Zinc Deficiency']}, 'descriptionModule': {'briefSummary': 'To study the effect of short-term zinc supplementation on improving inflammation, metabolic, and cardiovascular risk among HIV infected patients on stable anti-retroviral therapy', 'detailedDescription': 'This study will focus on subjects with documented zinc deficiency (levels \\<75 µg/dl) as group most likely to benefit from the zinc supplementation. The investigators also acknowledge that zinc may be beneficial in all HIV subjects, regardless of the plasma zinc level; however initial studies should be done in subjects with low zinc levels as they are more likely to benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* Documentation of an HIV-1 RNA level of ≤400 copies/mL in the last 4 months prior to study entry\n* Male or Female age ≥18 years\n* Zinc level ≤0.75 mg/L in the last 60 days\n\nExclusion Criteria:\n\n* Pregnancy/lactation\n* Known cardiovascular disease\n* Uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT05085834', 'briefTitle': 'Zinc Effect on Inflammation and Cardiovascular Risk in HIV', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Zinc Effect on Inflammation and Cardiovascular Risk in HIV', 'orgStudyIdInfo': {'id': 'Zinc study'}, 'secondaryIdInfos': [{'id': '1R21AT009153', 'link': 'https://reporter.nih.gov/quickSearch/1R21AT009153', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zinc gluconate', 'description': 'Patients received Zinc gluconate 45 mg capsules orally twice daily for 24 weeks.', 'interventionNames': ['Drug: Zinc Gluconate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients received Zinc gluconate Placebo capsules orally twice daily for 24 weeks.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Zinc Gluconate', 'type': 'DRUG', 'description': 'Two 45 mg capsules once daily', 'armGroupLabels': ['Zinc gluconate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Two placebo capsules once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Grace A McComsey, MD, FIDSA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Case Western Reserve University', 'class': 'OTHER'}, {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Grace McComsey', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}