MedTrace Logo

TB Nutrition, Immunology and Epidemiology

NCT00170404 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 887

Last updated 2010-08-27

No results posted yet for this study

Summary

The purpose of this study is to see whether people who take vitamins along with the standard medicine for tuberculosis (TB) recover better and quicker than people who take only the standard medicine for TB. This study will enroll 600 men and women, who are age 18-65 years, have TB, and intend to stay in Dar-es-Salaam for at least 2 years from the start of TB therapy. Half the participants will have active TB and also HIV infection, and the other half will have TB alone. Half the volunteers will be given vitamins, and the other half will be given placebo (sugar pill with no vitamins) from the start of their TB therapy, through the 8 months of anti-TB therapy, and up to 48 months. Participation in the study involves visits to the clinic, physical exams, home visits, and answering questions about personal health, foods eaten, household, occupation, and education. Volunteers will also provide blood, sputum, and urine samples.

Conditions

  • Mycobacterium Tuberculosis

Interventions

DRUG

Folic Acid

DRUG

Micronutrients: Vitamins B1, B2, B6, Niacin, B12, C, E.

DRUG

Selenium

DRUG

Vitamin A

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Completion
2005-10-31

Countries

  • Tanzania

Study Locations

More Related Trials

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 NCT00170404 on ClinicalTrials.gov