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

September 8, 2005
July 17, 2013
August 2002
February 2008   (final data collection date for primary outcome measure)
insulin resistance calculated using fasting glucose and fasting insulin levels in blood [ Time Frame: BL & 16 weeks ] [ Designated as safety issue: No ]
HOMA-IR
insulin resistance calculated usig fasting glucose and fasting insulin level in blood
Complete list of historical versions of study NCT00152893 on ClinicalTrials.gov Archive Site
  • 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 ]
  • HbA1c
  • blood lipid profile (TG, chol or HDL)
  • body composition by DEXA scan, BIOELECTRIC Impedance analysis and skin fold measurement
  • oxidative stress
  • plasma chromium
Not Provided
Not Provided
 
To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
HIV Infections
  • Drug: chromium nicotinate
  • Drug: Placebo
  • Experimental: Chromium
    400 μg (200 μg pills, twice per day) of Cr-nicotinate
    Intervention: Drug: chromium nicotinate
  • Placebo Comparator: Placebo
    Identical looking placebo (di-calcium phosphate)
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
February 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00152893
03-0703-A, 015 027
Not Provided
Johane Allard, University Health Network, Toronto
Johane Allard
Canadian Foundation for AIDS Research (CANFAR)
Principal Investigator: Johane Allard, MD, FRCPC University Health Network - Toronto General Hospital
University Health Network, Toronto
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP