- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00057434
Vitamin A Therapy for Tuberculosis
Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Zomba, Malawi
- Zomba Central Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Mortality
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Secondary Outcome Measures
Outcome Measure |
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Morbidity
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Collaborators and Investigators
Investigators
- Principal Investigator: Richard D. Semba, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01AI041956-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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