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
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