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

This study has been completed.
Sponsor:
Collaborator:
Canadian Foundation for AIDS Research (CANFAR)
Information provided by (Responsible Party):
Johane Allard, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152893
First received: September 8, 2005
Last updated: July 17, 2013
Last verified: July 2013
  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
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection

Resource links provided by NLM:


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 [ Time Frame: BL & 16 weeks ] [ Designated as safety issue: No ]
    HOMA-IR


Secondary Outcome Measures:
  • hemoglobin A1c (HbA1c) [ Time Frame: BL & 16 weeks ] [ Designated as safety issue: No ]
  • blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL]) [ Time Frame: BL & 16 weeks ] [ Designated as safety issue: No ]
  • body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement [ Time Frame: BL & 16 weeks ] [ Designated as safety issue: No ]
  • oxidative stress [ Time Frame: BL & 16 weeks ] [ Designated as safety issue: No ]
  • plasma chromium [ Time Frame: BL & 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 52
Study Start Date: August 2002
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chromium
400 μg (200 μg pills, twice per day) of Cr-nicotinate
Drug: chromium nicotinate
Placebo Comparator: Placebo
Identical looking placebo (di-calcium phosphate)
Drug: Placebo

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Johane Allard
Canadian Foundation for AIDS Research (CANFAR)
Investigators
Principal Investigator: Johane Allard, MD, FRCPC University Health Network - Toronto General Hospital
  More Information

Publications:
Responsible Party: Johane Allard, Gastroenterologist, Prof. of Medicine, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00152893     History of Changes
Other Study ID Numbers: 03-0703-A, 015 027
Study First Received: September 8, 2005
Last Updated: July 17, 2013
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

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Chromium
Niacin
Nicotinic Acids
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Therapeutic Uses
Vasodilator Agents
Cardiovascular Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on September 22, 2014