Clinical trial NCT00197704: Nutrition, Immunology and Epidemiology of Tuberculosis
Official title: Nutrition, Immunology and Epidemiology of Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberculosis
Keywords: Tuberculosis
HIV
Tanzania
multivitamins
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2005-09-20
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection.
timeFrame: Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up.
Secondary outcomes:
measure: To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters.
timeFrame: 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.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Wafaie W Fawzi, MD,DrPh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.