Tuberculosis Clinical Trial
Official title:
Nutrition, Immunology and Epidemiology of Tuberculosis
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
Status | Completed |
Enrollment | 876 |
Est. completion date | May 2004 |
Est. primary completion date | May 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Harvard School of Public Health | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Harvard School of Public Health | Muhimbili University of Health and Allied Sciences |
United States,
Villamor E, Mugusi F, Urassa W, Bosch RJ, Saathoff E, Matsumoto K, Meydani SN, Fawzi WW. A trial of the effect of micronutrient supplementation on treatment outcome, T cell counts, morbidity, and mortality in adults with pulmonary tuberculosis. J Infect D — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. | Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up. | No | |
Secondary | To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters. | 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. | No |
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