Nutrition, Immunology and Epidemiology of Tuberculosis

Tuberculosis Clinical Trial

Official title:

Nutrition, Immunology and Epidemiology of Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197704
• Other study ID #: AI45441
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 9, 2010
• Start date: March 2000
• Est. completion date: May 2004

Study information

• Verified date: November 2010
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
United States	Harvard School of Public Health	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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