Back to resultsTo Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
chromium nicotinate
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, blood sugar > 6.1 mmol/l, triglycerides > 2 mmol/l, total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l
Eligibility 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.
Sites / Locations
- University Health Network - Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Chromium
Placebo
Arm Description
400 μg (200 μg pills, twice per day) of Cr-nicotinate
Identical looking placebo (di-calcium phosphate)
Outcomes
Primary Outcome Measures
insulin resistance calculated using fasting glucose and fasting insulin levels in blood
HOMA-IR
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
Full Information
NCT ID
NCT00152893
First Posted
September 8, 2005
Last Updated
July 17, 2013
Sponsor
Johane Allard
Collaborators
Canadian Foundation for AIDS Research (CANFAR)
1. Study Identification
Unique Protocol Identification Number
NCT00152893
Brief Title
To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
Official Title
The Effects of Chromium Supplementation on Glucose and Lipid Metabolism in Patients With HIV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Johane Allard
Collaborators
Canadian Foundation for AIDS Research (CANFAR)
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, blood sugar > 6.1 mmol/l, triglycerides > 2 mmol/l, total cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chromium
Arm Type
Experimental
Arm Description
400 μg (200 μg pills, twice per day) of Cr-nicotinate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical looking placebo (di-calcium phosphate)
Intervention Type
Drug
Intervention Name(s)
chromium nicotinate
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
insulin resistance calculated using fasting glucose and fasting insulin levels in blood
Description
HOMA-IR
Time Frame
BL & 16 weeks
Secondary Outcome Measure Information:
Title
hemoglobin A1c (HbA1c)
Time Frame
BL & 16 weeks
Title
blood lipid profile (triglycerides [TG], cholesterol or high-density lipoprotein [HDL])
Time Frame
BL & 16 weeks
Title
body composition by dual energy x-ray absorptiometry (DEXA) scan, bioelectric impedance analysis and skin fold measurement
Time Frame
BL & 16 weeks
Title
oxidative stress
Time Frame
BL & 16 weeks
Title
plasma chromium
Time Frame
BL & 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johane Allard, MD, FRCPC
Organizational Affiliation
University Health Network - Toronto General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network - Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
17308254
Citation
Aghdassi E, Arendt B, Salit IE, Allard JP. Estimation of body fat mass using dual-energy x-ray absorptiometry, bioelectric impedance analysis, and anthropometry in HIV-positive male subjects receiving highly active antiretroviral therapy. JPEN J Parenter Enteral Nutr. 2007 Mar-Apr;31(2):135-41. doi: 10.1177/0148607107031002135.
Results Reference
background
PubMed Identifier
20163347
Citation
Aghdassi E, Arendt BM, Salit IE, Mohammed SS, Jalali P, Bondar H, Allard JP. In patients with HIV-infection, chromium supplementation improves insulin resistance and other metabolic abnormalities: a randomized, double-blind, placebo controlled trial. Curr HIV Res. 2010 Mar;8(2):113-20. doi: 10.2174/157016210790442687.
Results Reference
result
PubMed Identifier
18288980
Citation
Arendt BM, Aghdassi E, Mohammed SS, Fung LY, Jalali P, Salit IE, Allard JP. Dietary intake and physical activity in a Canadian population sample of male patients with HIV infection and metabolic abnormalities. Curr HIV Res. 2008 Jan;6(1):82-90. doi: 10.2174/157016208783571973.
Results Reference
result
Learn more about this trial
To Determine if Chromium Nicotinate Supplementation Will Improve Insulin Resistance in HIV Patients With Metabolic Abnormalities
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