Vitamin A Therapy for Tuberculosis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Tuberculosis HIV Infections |
Drug: multivitamin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Adjunct Vitamin A Therapy for Tuberculosis and HIV/AIDS |
- Mortality
- Morbidity
| Estimated Enrollment: | 1140 |
| Study Start Date: | September 1998 |
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided by National Institute of Allergy and Infectious Diseases (NIAID)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00057434 History of Changes |
| Other Study ID Numbers: | 5R01AI41956-05 |
| Study First Received: | April 1, 2003 |
| Last Updated: | September 17, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Vitamin A |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Tuberculosis Tuberculosis, Pulmonary Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Mycobacterium Infections Actinomycetales Infections |
Gram-Positive Bacterial Infections Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Vitamin A Vitamins Retinol palmitate Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013