Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT00152893
Status:
COMPLETED
Last Update Posted:
2013-07-19
First Post:
2005-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-25', 'releaseDate': '2023-05-15'}], 'estimatedResultsFirstSubmitDate': '2023-05-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C102874', 'term': 'chromium nicotinic acid complex'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-17', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2013-07-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'insulin resistance calculated using fasting glucose and fasting insulin levels in blood', 'timeFrame': 'BL & 16 weeks', 'description': 'HOMA-IR'}], 'secondaryOutcomes': [{'measure': 'hemoglobin A1c (HbA1c)', 'timeFrame': 'BL & 16 weeks'}, {'measure': 'blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL])', 'timeFrame': 'BL & 16 weeks'}, {'measure': 'body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement', 'timeFrame': 'BL & 16 weeks'}, {'measure': 'oxidative stress', 'timeFrame': 'BL & 16 weeks'}, {'measure': 'plasma chromium', 'timeFrame': 'BL & 16 weeks'}]}, 'conditionsModule': {'keywords': ['HIV', 'blood sugar > 6.1 mmol/l', 'triglycerides > 2 mmol/l', 'total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17308254', 'type': 'BACKGROUND', 'citation': 'Aghdassi E, Arendt B, Salit IE, Allard JP. Estimation of body fat mass using dual-energy x-ray absorptiometry, bioelectric impedance analysis, and anthropometry in HIV-positive male subjects receiving highly active antiretroviral therapy. JPEN J Parenter Enteral Nutr. 2007 Mar-Apr;31(2):135-41. doi: 10.1177/0148607107031002135.'}, {'pmid': '20163347', 'type': 'RESULT', 'citation': 'Aghdassi E, Arendt BM, Salit IE, Mohammed SS, Jalali P, Bondar H, Allard JP. In patients with HIV-infection, chromium supplementation improves insulin resistance and other metabolic abnormalities: a randomized, double-blind, placebo controlled trial. Curr HIV Res. 2010 Mar;8(2):113-20. doi: 10.2174/157016210790442687.'}, {'pmid': '18288980', 'type': 'RESULT', 'citation': 'Arendt BM, Aghdassi E, Mohammed SS, Fung LY, Jalali P, Salit IE, Allard JP. Dietary intake and physical activity in a Canadian population sample of male patients with HIV infection and metabolic abnormalities. Curr HIV Res. 2008 Jan;6(1):82-90. doi: 10.2174/157016208783571973.'}]}, 'descriptionModule': {'briefSummary': 'In HIV patients, fasting insulin levels decrease with chromium supplementation. This study is to determine if chromium nicotinate supplementation at 400ug/day for 16 weeks will improve insulin resistance in HIV patients with metabolic abnormalities.', 'detailedDescription': 'This study is a randomized, double-blind, placebo-controlled, crossover study where patients will be supplemented for 16 weeks with either chromium nicotinate 400 ug/day or placebo and then crossover to the opposite treatment for another 16 weeks. Each soft gel capsule of chromium contains 200ug of chromium and patients will take 1 capsule twice a day or its placebo. Placebo contains di-calcium phosphate in a soft gel capsule and its appearance is similar to the chromium capsules.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV documented patients will be considered for the study if they have at least one abnormality with respect to fasting blood glucose, TG, total or HDL cholesterol. Normal fasting glucose is defined as \\< 6.1 mmol/L. Hypertriglyceridemia is defined as concentrations above 2.0 mmol/L on the basis of reports of increased risk of cardiac disease. Hypercholesterolemia is defined as concentrations above 5.5 mmol/L and a low HDL-cholesterol concentration as less than 0.9 mmol/L.\n* Patients will need to be on a stable drug regimen for at least 8 weeks and not taking any chromium supplement or chromium-containing multivitamins 4 weeks prior to and during the study period. Patients can stay on their hypoglycemic or lipid-lowering medications and the required dosage will be monitored.\n\nExclusion Criteria:\n\n* Patients will be excluded if there is concomitant acute infection or malignancy.'}, 'identificationModule': {'nctId': 'NCT00152893', 'briefTitle': 'To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection', 'orgStudyIdInfo': {'id': '03-0703-A'}, 'secondaryIdInfos': [{'id': '015 027'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chromium', 'description': '400 μg (200 μg pills, twice per day) of Cr-nicotinate', 'interventionNames': ['Drug: chromium nicotinate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical looking placebo (di-calcium phosphate)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'chromium nicotinate', 'type': 'DRUG', 'armGroupLabels': ['Chromium']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network - Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Johane Allard, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network - Toronto General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johane Allard', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Foundation for AIDS Research (CANFAR)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gastroenterologist, Prof. of Medicine', 'investigatorFullName': 'Johane Allard', 'investigatorAffiliation': 'University Health Network, Toronto'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-15', 'type': 'RELEASE'}, {'date': '2024-01-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Johane Allard, Gastroenterologist, Prof. of Medicine, University Health Network, Toronto'}}}}