Nutrition, Immunology and Epidemiology of Tuberculosis

Phase 3

Completed

• Conditions: Tuberculosis
• Interventions: Other: Placebo; Dietary Supplement: Multivitamins

• Registration Number: NCT00197704
• Lead Sponsor: Harvard School of Public Health (HSPH)

Brief 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.

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 876

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Multivitamins	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

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Harvard School of Public Health; 🇺🇸 Boston, Massachusetts, United States