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Nutrition, Immunology and Epidemiology of Tuberculosis

NCT ID: NCT00197704

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

876 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2004-05-31

Brief Summary

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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

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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

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Tuberculosis

Keywords

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Tuberculosis HIV Tanzania multivitamins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Multivitamins

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Harvard School of Public Health

Principal Investigators

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Wafaie W Fawzi, MD,DrPh

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

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Harvard School of Public Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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 Dis. 2008 Jun 1;197(11):1499-505. doi: 10.1086/587846.

Reference Type RESULT
PMID: 18471061 (View on PubMed)

Mehta S, Mugusi FM, Bosch RJ, Aboud S, Urassa W, Villamor E, Fawzi WW. Vitamin D status and TB treatment outcomes in adult patients in Tanzania: a cohort study. BMJ Open. 2013 Nov 18;3(11):e003703. doi: 10.1136/bmjopen-2013-003703.

Reference Type DERIVED
PMID: 24247327 (View on PubMed)

Other Identifiers

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AI45441

Identifier Type: -

Identifier Source: org_study_id