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Vitamin A Therapy for Tuberculosis

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Tuberculosis; HIV Infections

Intervention: multivitamin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
Richard D. Semba, MD, Principal Investigator, Affiliation: Johns Hopkins University

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.

Clinical Details

Official title: Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Mortality

Secondary outcome: Morbidity

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Zomba Central Hospital, Zomba, Malawi
Additional Information

Starting date: September 1998
Last updated: September 17, 2007

Page last updated: August 20, 2015

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