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| ID | Type | Description | Link |
|---|---|---|---|
| 015 027 |
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| Name | Class |
|---|---|
| Canadian Foundation for AIDS Research (CANFAR) | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chromium | Experimental | 400 μg (200 μg pills, twice per day) of Cr-nicotinate |
|
| Placebo | Placebo Comparator | Identical looking placebo (di-calcium phosphate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chromium nicotinate | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| insulin resistance calculated using fasting glucose and fasting insulin levels in blood | HOMA-IR | BL & 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| hemoglobin A1c (HbA1c) | BL & 16 weeks | |
| blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL]) | BL & 16 weeks | |
| body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johane Allard, MD, FRCPC | University Health Network - Toronto General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network - Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17308254 | Background | 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. | |
| 20163347 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2023 | |
| Reset | Jan 25, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2023 | Jan 25, 2024 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C102874 | chromium nicotinic acid complex |
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|
| BL & 16 weeks |
| oxidative stress | BL & 16 weeks |
| plasma chromium | BL & 16 weeks |
| 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. |
| 18288980 | Result | 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. |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |