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Micronutrients and Antioxidants in HIV Infection

NCT00798772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2018-04-17

No results posted yet for this study

Summary

Infection with human immunodeficiency virus (HIV) causes decline in immunity or the ability to fight infection and progresses to acquired immunodeficiency disease (AIDS). Anti-HIV drug treatment has improved the prognosis of persons with HIV infection, but is expensive and potentially toxic. Low micronutrient levels occur in the blood even in early stages of HIV infection and increase risk of a poorer prognosis, but the role of micronutrient and antioxidant supplements in medical management of HIV/AIDS is not well defined. The proposed clinical trial aims to assess if supplementation of untreated HIV-infected adults with a micronutrient and antioxidant preparation can delay decline in immunity or disease progression or start of anti-HIV drug treatment compared with supplementation with standard multivitamins. If the findings are positive, the study has implications for health and health care savings.

Conditions

  • HIV Infection

Interventions

DIETARY_SUPPLEMENT

Micronutrients and antioxidants

8 capsules twice daily for two years

DIETARY_SUPPLEMENT

Multivitamins and minerals

8 capsules twice daily for two years

Sponsors & Collaborators

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • Ontario HIV Treatment Network

    collaborator NETWORK

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • William Cameron, MD, FRCPC · University of Ottawa at The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-05-31
Completion
2017-12-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00798772 on ClinicalTrials.gov