NCT00197704

Nutrition, Immunology and Epidemiology of Tuberculosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 876 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
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
OTHER	Placebo	Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy

Timeline

• Start date: 2000-03-01
• Primary completion: 2004-05-01
• Completion: 2004-05-01
• First posted: 2005-09-20
• Last updated: 2010-11-11

Locations

1 site across 1 country: United States