To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Drug: Placebo; Drug: chromium nicotinate

• Registration Number: NCT00152893
• Lead Sponsor: Johane Allard

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2002-08
• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-17
• Last Update Posted: 2013-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Identical looking placebo (di-calcium phosphate)
Chromium	chromium nicotinate	400 μg (200 μg pills, twice per day) of Cr-nicotinate

Primary Outcome Measures

Name	Time	Method
insulin resistance calculated using fasting glucose and fasting insulin levels in blood	BL & 16 weeks	HOMA-IR

Secondary Outcome Measures

Name	Time	Method
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	BL & 16 weeks
oxidative stress	BL & 16 weeks
plasma chromium	BL & 16 weeks

Trial Locations

Locations (1)

University Health Network - Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada