Nutrition, Immunology and Epidemiology of Tuberculosis
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The purpose of this study is to determine the efficacy of micronutrient supplementation among patients with active tuberculosis, half of who are co-infected with HIV-1
Condition | Intervention | Phase |
---|---|---|
Tuberculosis |
Dietary Supplement: Multivitamins Other: Placebo |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | Nutrition, Immunology and Epidemiology of Tuberculosis |
- To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. [ Time Frame: Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up. ] [ Designated as safety issue: No ]
- To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters. [ Time Frame: Rate of change of HIV viral load in HIV positive patients: 2, 5, 8, and 20 months; Absolute change in CD4 counts: 2, 5, 8, and 20 months; Weight change from baseline: 2, 8, and 20 months; Immunological parameters: 2, 8, and 20 months. ] [ Designated as safety issue: No ]
Enrollment: | 876 |
Study Start Date: | March 2000 |
Study Completion Date: | May 2004 |
Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo Comparator: Placebo
Placebo
|
Other: Placebo
Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
|
Experimental: Multivitamins
5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium
|
Dietary Supplement: Multivitamins
5000 IU of retinol, 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 of C, 200 mg of E, 0.8 mg of folic acid, and 100 mcg of selenium taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
|
Detailed Description:
Tuberculosis (TB) remains the single most common infectious disease cause of mortality. We propose to examine the inter- relationships of nutrition, immunology, and epidemiology with respect to TB in Tanzania. Given that TB is so much linked with HIV immunologically, clinically, and epidemiologically, it is essential to examine how these relationships are modified by HIV infection. Published animal and human studies suggest that vitamin deficiency is associated with poor immune response in TB. By modulating immune function, nutritional supplements may be a useful adjunct to anti-TB drugs, and could lead to the development of shorter drug regimens. All patients will receive standard anti-TB therapy. Follow-up visits will occur every two weeks for the first 2 months and monthly thereafter till the end of the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women, age 18 to 60 years inclusive
- At least two positive sputum smears for tuberculosis
- Intention to stay in Dar-es-Salaam for at least 2 years after the start of TB therapy
- Subjects who grant informed consent to participation
Exclusion Criteria:
- Karnofsky score < 40%
- Hemoglobin < 8.5 g/dl
- Having had treatment for TB exceeding 4 weeks in the last 5 years
- Pregnant women
United States, Massachusetts | |
Harvard School of Public Health | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Wafaie W Fawzi, MD,DrPh | Harvard School of Public Health |
Publications:
Responsible Party: | Wafaie Fawzi, Harvard School of Public Health |
ClinicalTrials.gov Identifier: | NCT00197704 History of Changes |
Other Study ID Numbers: | AI45441 |
Study First Received: | September 12, 2005 |
Last Updated: | November 9, 2010 |
Health Authority: | United States: Institutional Review Board Tanzania: National Institute for Medical Research |
Keywords provided by Harvard School of Public Health:
Tuberculosis HIV Tanzania multivitamins |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on March 03, 2013