Vitamin A Therapy for Tuberculosis

Phase 3

Completed

• Conditions: Pulmonary Tuberculosis; HIV Infections

• Registration Number: NCT00057434
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

The study will determine whether a daily vitamin and mineral supplement (a multivitamin including Vitamin A) will improve health when added to standard chemotherapy for tuberculosis. This study will compare the effectiveness of the multivitamin in HIV infected and HIV uninfected patients.

Detailed Description

By the year 2000, 13.8 % of individuals with HIV will be co-infected with tuberculosis (TB). Despite effective TB chemotherapy, mortality rates remain extremely high, and no simple, inexpensive intervention is available. Prior to the discovery of antibiotic treatment, cod-liver oil, a potent source of Vitamin A, was the standard treatment for TB. Vitamin A is essential for normal immune function, and Vitamin A supplementation is used in many countries to reduce mortality in children. Vitamin A deficiency in HIV infected people has been associated with increased mortality in the United States, Haiti, Malawi, and Uganda. This study will determine whether daily Vitamin A supplementation, given concurrently with TB chemotherapy, will reduce mortality in adults with HIV and TB.

All study participants will receive standard TB chemotherapy (isoniazid, rifampicin, streptomycin, pyrazinamide) for the first 2 months, followed by isoniazid and ethambutol for the following 6 months. Participants will be randomized to receive either a daily vitamin and mineral supplement or placebo. Participants will be followed for 24 months after study enrollment.

Study Timeline

• Study Start: 1998-09
• Study First Submitted: 2003-04-01
• Study First Submitted QC: 2003-04-02
• Study First Posted: 2003-04-03
• Status Verified: 2007-08
• Last Update Submitted: 2007-09-17
• Last Update Posted: 2007-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1140

Inclusion Criteria

• Sputum-confirmed pulmonary tuberculosis
• Resident of Zomba or Blantyre Districts, Malawi
• Willing to take tuberculosis chemotherapy as recommended by the National Tuberculosis Control Programme

Exclusion Criteria

• Prior treatment for tuberculosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mortality

Secondary Outcome Measures

Name	Time	Method
Morbidity

Trial Locations

Locations (1)

Zomba Central Hospital; 🇲🇼 Zomba, Malawi