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Nutrition, Immunology and Epidemiology of Tuberculosis

NCT00197704 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 876

Last updated 2010-11-11

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1

Conditions

Interventions

DIETARY_SUPPLEMENT

Multivitamins

5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy

OTHER

Placebo

Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy

Sponsors & Collaborators

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2004-05-31
Completion
2004-05-31

Countries

  • United States

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 NCT00197704 on ClinicalTrials.gov