NCT00152893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2 hiv-infections

Timeline
Completed

Started Aug 2002

Longer than P75 for phase_2 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

July 19, 2013

Status Verified

July 1, 2013

Enrollment Period

5.5 years

First QC Date

September 8, 2005

Last Update Submit

July 17, 2013

Conditions

HIV Infections

Keywords

HIVblood sugar > 6.1 mmol/ltriglycerides > 2 mmol/ltotal cholesterol > 5.5 mmol/l or HDL < 0.9 mmol/l

Outcome Measures

Primary Outcomes (1)

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

    HOMA-IR

    BL & 16 weeks

Secondary Outcomes (5)

  • hemoglobin A1c (HbA1c)

    BL & 16 weeks

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

    BL & 16 weeks

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

    BL & 16 weeks

  • oxidative stress

    BL & 16 weeks

  • plasma chromium

    BL & 16 weeks

Study Arms (2)

Chromium

EXPERIMENTAL

400 μg (200 μg pills, twice per day) of Cr-nicotinate

Drug: chromium nicotinate

Placebo

PLACEBO COMPARATOR

Identical looking placebo (di-calcium phosphate)

Drug: Placebo

Interventions

chromium nicotinateDRUG
Chromium
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients will be excluded if there is concomitant acute infection or malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network - Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (3)

  • 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.

    PMID: 17308254BACKGROUND

  • 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.

    PMID: 20163347RESULT

  • 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.

    PMID: 18288980RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

chromium nicotinic acid complex

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Johane Allard, MD, FRCPC

    University Health Network - Toronto General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Gastroenterologist, Prof. of Medicine

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

August 1, 2002

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

July 19, 2013

Record last verified: 2013-07

Locations

CA(1)