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

J

Johane Allard

Status and phase

Completed
Phase 2

Conditions

HIV Infections

Treatments

Drug: Placebo
Drug: chromium nicotinate

Study type

Interventional

Funder types

Other

Identifiers

NCT00152893
03-0703-A
015 027

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

52 participants in 2 patient groups, including a placebo group

Chromium
Experimental group
Description:
400 μg (200 μg pills, twice per day) of Cr-nicotinate
Treatment:
Drug: chromium nicotinate
Placebo
Placebo Comparator group
Description:
Identical looking placebo (di-calcium phosphate)
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems