Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02856269
Status:
COMPLETED
Last Update Posted:
2022-02-11
First Post:
2016-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Zinc Supplementation and Cardiovascular Risk in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], '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': '216-8442739', 'title': 'Dr. Grace McComsey', 'organization': 'University Hospitals Cleveland Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Due to the small sample size and short study period, we cannot establish causation. We did not include a placebo control group for comparison. Our study focused on participants with treated HIV and documented zinc deficiency in the United States. We did not obtain dietary or physical activity patterns. Participants with treated HIV and documented zinc deficiency resided in the United States, therefore our findings cannot be generalized to different populations or to resource limited settings.'}}, 'adverseEventsModule': {'timeFrame': '16 Weeks', 'description': 'At entry, weeks 4,10, and 16, All-Cause Mortality and Serious Adverse Events were assessed.', 'eventGroups': [{'id': 'EG000', 'title': '45 mg Daily', 'description': 'Participants in this arm take a daily 45 mg dose of zinc gluconate.\n\nParticipants were interviewed for side effects at baseline and at week 16.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '90 mg Daily', 'description': 'Participants in this arm take a daily 90 mg dose of zinc gluconate.\n\nParticipants were interviewed for side effects at baseline and at week 16.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 1, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '45 mg Daily', 'description': 'Participants in this arm will take a daily 45 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}, {'id': 'OG001', 'title': '90 mg Daily', 'description': 'Participants in this arm will take a daily 90 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}], 'classes': [{'title': 'sCD14', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'sTNF-RI', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'hs-CRP', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': "Cohen's D value", 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.8', 'estimateComment': "The Cohen's d is calculated after Box-Cox transformation. Small effect \\<= 0.2, Medium effect \\[0.3, 0.8\\]; Large effect \\>0.8", 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Wilcoxon rank sum tests, X2 tests, Fisher exact tests, Kolmogorov-Smirnov'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and 16 Weeks', 'description': 'Percentage of participants with the following inflammatory markers decrease (sCD14) Soluble cluster of differentiation 14, (sTNF-RI) soluble Tumor Necrosis Factor alpha receptor I, (hs-CRP) High sensitivity C-reactive protein. These inflammatory markers are measured in the blood by enzyme-linked immunoassay ELISA.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population (all participants assigned to zinc 45 mmg or zinc 90 mg).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Reached the Zinc Sufficient Level After Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '45 mg Daily', 'description': 'Participants in this arm will take a daily 45 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}, {'id': 'OG001', 'title': '90 mg Daily', 'description': 'Participants in this arm will take a daily 90 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}], 'classes': [{'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 Weeks', 'description': 'After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels \\>75 μg/dL.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '45 mg Daily', 'description': 'Participants in this arm will take a daily 45 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}, {'id': 'FG001', 'title': '90 mg Daily', 'description': 'Participants in this arm will take a daily 90 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited based on physician referral at University Hospitals Cleveland Medical Center between September 2016 and February 2018.', 'preAssignmentDetails': 'Of 118 patients screened, 52 met inclusion criteria and were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '45 mg Daily', 'description': 'Participants in this arm will take a daily 45 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}, {'id': 'BG001', 'title': '90 mg Daily', 'description': 'Participants in this arm will take a daily 90 mg dose of zinc gluconate.\n\nZinc gluconate: Participants will take a daily dose of zinc gluconate.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '60'}, {'value': '47', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '54.50'}, {'value': '49', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Zinc levels', 'classes': [{'categories': [{'measurements': [{'value': '74.00', 'groupId': 'BG000', 'lowerLimit': '64.00', 'upperLimit': '83.00'}, {'value': '73.00', 'groupId': 'BG001', 'lowerLimit': '66.00', 'upperLimit': '86.00'}, {'value': '73', 'groupId': 'BG002', 'lowerLimit': '64', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'description': 'Median and Inter-Quartile range of zinc blood levels in μg/dL', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-08', 'size': 5090724, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-08-18T12:32', 'hasProtocol': True}, {'date': '2017-11-14', 'size': 3176069, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-08-18T12:07', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients and the research nurse are unblinded. The research assistant and the principle investigator are blinded.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a pilot open labeled randomized double arm trial, studying zinc supplementation to prevent HIV comorbidities that are linked to inflammation. Patients will be given zinc gluconate 45 mg capsule once daily in one arm, and 90 mg zinc gluconate in the other arm for 16 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-10', 'studyFirstSubmitDate': '2016-07-29', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-10', 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Decreased Inflammation Markers sCD14, sTNF-RI, and High Sensitivity C Reactive Protein (Hs-CRP)', 'timeFrame': 'Baseline and 16 Weeks', 'description': 'Percentage of participants with the following inflammatory markers decrease (sCD14) Soluble cluster of differentiation 14, (sTNF-RI) soluble Tumor Necrosis Factor alpha receptor I, (hs-CRP) High sensitivity C-reactive protein. These inflammatory markers are measured in the blood by enzyme-linked immunoassay ELISA.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants That Reached the Zinc Sufficient Level After Treatment', 'timeFrame': '16 Weeks', 'description': 'After treatment, zinc was measured in the blood. Patients are considered sufficient if zinc levels \\>75 μg/dL.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Zinc'], 'conditions': ['HIV', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to determine whether zinc supplementation significantly affects immune activation in HIV-infected subjects.', 'detailedDescription': 'Zinc is a dietary supplement with compelling preclinical evidence for potential health benefit that could be expanded not only to the entire HIV population, but also to other inflammatory conditions that share many facets of HIV infection, namely the persistent intestinal barrier dysfunction, monocyte activation and heightened inflammation state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection\n* Age ≥18 years\n* Zinc level ≤0.75 mg/L\n* Receiving a stable antiretroviral regimen with no plans to change during study\n* Documentation of an HIV-1 RNA level of ≤400 copies/mL\n* No diarrhea or nausea/vomiting for the last month\n\nExclusion Criteria:\n\n* Pregnancy/lactation\n* Presence of inflammatory condition\n* Regular use of agents that may affect inflammation in the last 3 months. The regular use of NSAIDS, aspirin, or statins will be allowed as long as dose has been stable for the last 3 months and is not expected to change during the study.\n* Presence of active neoplastic diseases requiring chemotherapy and/or use of immunosuppressive drugs\n* Known cardiovascular disease\n* Uncontrolled diabetes\n* Allergy or intolerance to zinc sulfate.\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 2.5 x Upper limit of normal (ULN)\n* Hemoglobin \\< 9.0 g/dL\n* glomerular filtration rate (GFR) \\< 50 mL/min'}, 'identificationModule': {'nctId': 'NCT02856269', 'briefTitle': 'Zinc Supplementation and Cardiovascular Risk in HIV', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Zinc Supplementation and Cardiovascular Risk in HIV', 'orgStudyIdInfo': {'id': '02-15-07'}, 'secondaryIdInfos': [{'id': '1R21AT009153-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21AT009153-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '45 mg daily', 'description': 'Participants in this arm will take a daily 45 mg dose of zinc gluconate.', 'interventionNames': ['Dietary Supplement: Zinc gluconate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '90 mg daily', 'description': 'Participants in this arm will take a daily 90 mg dose of zinc gluconate.', 'interventionNames': ['Dietary Supplement: Zinc gluconate']}], 'interventions': [{'name': 'Zinc gluconate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take a daily dose of zinc gluconate.', 'armGroupLabels': ['45 mg daily', '90 mg daily']}]}, '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 McComsey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grace McComsey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Grace McComsey', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}