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Multi-vitamins, HAART and HIV/AIDS in Uganda

NCT01228578 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2014-05-22

No results posted yet for this study

Summary

The investigators are conducting a double-blind, placebo controlled,randomized trial of multivitamin supplements(containing B-vitamins, C, and E) to determine their efficacy in slowing disease progression, indicated by increased CD4 count, weight gain, and improved quality of life, and decreased morbidity, mortality, and drug-related adverse events (i.e. peripheral neuropathy, anemia, and diarrhea).

The investigators hypothesize that daily multivitamin supplementation will: (1) improve immune reconstitution; (2) improve weight gain, and (3) improve quality of life.

Conditions

Interventions

DIETARY_SUPPLEMENT

Multivitamin supplements B,C and E

One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months

Sponsors & Collaborators

  • Makerere University

    collaborator OTHER

  • Infectious Disease Institute, Kampala, Uganda

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Wafaie W Fawzi, MD,MPH,DrPH · Harvard School of Public Health (HSPH)

  • David Guwatudde, MPH, PhD · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

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 NCT01228578 on ClinicalTrials.gov