Trial | NCT00152893  Report issue

Title

To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    niacin ...

  • Study Participants

    52
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.
Study Started
Aug 31
2002
Primary Completion
Feb 29
2008
Study Completion
Feb 29
2008
Last Update
Jul 19
2013
Estimate

Drug chromium nicotinate

Drug Placebo

Chromium Experimental

400 μg (200 μg pills, twice per day) of Cr-nicotinate

Placebo Placebo Comparator

Identical looking placebo (di-calcium phosphate)

Criteria 

Inclusion Criteria:

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.
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.

Exclusion Criteria:

Patients will be excluded if there is concomitant acute infection or malignancy.
No Results Posted