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Sponsors and Collaborators: |
University Health Network, Toronto Canadian Foundation for AIDS Research (CANFAR) |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00152893 |
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Drug: chromium nicotinate |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Crossover Assignment |
Official Title: | The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection |
Estimated Enrollment: | 68 |
Study Start Date: | August 2002 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ellie Aghdassi, PhD, RD | 416-340-4800 ext 4413 | ellie.aghdassi@uhn.on.ca |
Canada, Ontario | |
University Health Network - Toronto General Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Contact: Ellie Aghdassi, PhD, RD 416-340-4800 ext 4413 ellie.aghdassi@uhn.on.ca | |
Principal Investigator: Johane Allard, MD, FRCPC |
Principal Investigator: | Johane Allard, MD, FRCPC | University Health Network - Toronto General Hospital |
Study ID Numbers: | 03-0703-A, 015 027 |
Study First Received: | September 8, 2005 |
Last Updated: | March 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00152893 |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
HIV blood sugar > 6.1 mmol/l triglycerides > 2 mmol/l total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l |
Sexually Transmitted Diseases, Viral Chromium Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Insulin Virus Diseases Nicotinic Acids |
HIV Infections Sexually Transmitted Diseases Insulin Resistance Congenital Abnormalities Retroviridae Infections Niacin |
Antimetabolites Communicable Diseases RNA Virus Infections Vasodilator Agents Vitamin B Complex Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Antilipemic Agents Growth Substances |
Physiological Effects of Drugs Trace Elements Cardiovascular Agents Infection Pharmacologic Actions Vitamins Therapeutic Uses Lentivirus Infections Micronutrients |