Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pulmonary Tuberculosis
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrollment
- 1140
- Locations
- 1
- Primary Endpoint
- Mortality
- Status
- Completed
- Last Updated
- 18 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mortality
Secondary Outcomes
- Morbidity