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OpenTrials
Completed

NCT Number: NCT00152893

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

chromium nicotinate

Drug

Placebo

Drug

Primary outcomes

  1. insulin resistance calculated using fasting glucose and fasting insulin levels in blood

    Time frame: BL & 16 weeks

    HOMA-IR

Secondary outcomes

  1. hemoglobin A1c (HbA1c)

    Time frame: BL & 16 weeks

  2. blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL])

    Time frame: BL & 16 weeks

  3. body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement

    Time frame: BL & 16 weeks

  4. oxidative stress

    Time frame: BL & 16 weeks

  5. plasma chromium

    Time frame: BL & 16 weeks

Sponsors and collaborators

Lead sponsor

Johane Allard

Other

Collaborators

  • Canadian Foundation for AIDS Research (CANFAR)

Registry information

Official study title

The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2005
Registry last updated
Jul 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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