A Phase 3 interventional study of Multivitamins and Placebo in Tuberculosis, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-11.
Sponsored by Harvard School of Public Health (HSPH) · Phase 3, Interventional, and Prevention
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
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 876 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →Harvard School of Public Health (HSPH) is the lead sponsor of 150 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Placebo
Other: Placebo
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
Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
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.
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.
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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Harvard School of Public Health (HSPH)