Vitamin A Therapy for Tuberculosis
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|ClinicalTrials.gov Identifier: NCT00057434|
Recruitment Status : Completed
First Posted : April 3, 2003
Last Update Posted : September 18, 2007
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Tuberculosis HIV Infections||Drug: multivitamin||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||1140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS|
|Study Start Date :||September 1998|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057434
|Zomba Central Hospital|
|Principal Investigator:||Richard D. Semba, MD||Johns Hopkins University|