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

This study has been completed.

First Received: September 8, 2005 Last Updated: March 26, 2009 History of Changes

Sponsors and Collaborators:	University Health Network, Toronto Canadian Foundation for AIDS Research , Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00152893

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: chromium nicotinate	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS Cholesterol Dietary Supplements

Drug Information available for: Niacin Chromium nicotinate Niacin hydrochloride Chromium

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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

Secondary Outcome Measures:

hemoglobin A1c (HbA1c)
blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL])
body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement
oxidative stress
plasma chromium

Estimated Enrollment:	68
Study Start Date:	August 2002
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152893

Locations

Canada, Ontario
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Canadian Foundation for AIDS Research , Toronto

Investigators

Principal Investigator:

Johane Allard, MD, FRCPC

University Health Network - Toronto General Hospital

More Information

No publications provided

Study ID Numbers:	03-0703-A, 015 027
Study First Received:	September 8, 2005
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00152893 History of Changes
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by University Health Network, Toronto:

HIV
blood sugar > 6.1 mmol/l
triglycerides > 2 mmol/l
total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l

Study placed in the following topic categories:

Antimetabolites
Sexually Transmitted Diseases, Viral
Vasodilator Agents
Niacinamide
Insulin
Nicotinamide
Nicotinic Acids
Vitamins
Micronutrients
Congenital Abnormalities
Nicotinic Acid
Retroviridae Infections
Vitamin B Complex

Chromium
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Trace Elements
Cardiovascular Agents
Immunologic Deficiency Syndromes
Virus Diseases
Vitamin B3
HIV Infections
Sexually Transmitted Diseases
Insulin Resistance
Niacin

Additional relevant MeSH terms:

Antimetabolites
Communicable Diseases
Sexually Transmitted Diseases, Viral
Vasodilator Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Infection
Nicotinic Acids
Vitamins
Therapeutic Uses
Micronutrients
Retroviridae Infections
RNA Virus Infections
Vitamin B Complex

Immune System Diseases
Chromium
Growth Substances
Antilipemic Agents
Acquired Immunodeficiency Syndrome
Trace Elements
Cardiovascular Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Niacin

ClinicalTrials.gov processed this record on August 30, 2009