drugset / Trial / NCT00170404

TB Nutrition, Immunology and Epidemiology

NCT00170404

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2000-06
Primary completion
Completion
2005-10

Drugs

EvaluationDrugModalityDoseRoute
Subject B1 Unknown 20 mg Oral
Subject B12 Other / unclassified 50 ug Oral
Subject B2 Unknown 20 mg Oral
Subject B6 Other / unclassified 25 mg Oral
Subject C Unknown Oral
Subject E Unknown 200 mg Oral
Subject Niacin Small molecule 100 mg Oral
Subject Retinol Unknown 5000 iu Oral
Subject Selenium Other / unclassified 100 ug Oral
Subject folic acid Other / unclassified 0.8 mg Oral

Indications