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Nutrition, Immunology and Epidemiology of Tuberculosis

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197704
First received: September 12, 2005
Last updated: November 9, 2010
Last verified: November 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Tuberculosis
 Dietary Supplement: Multivitamins
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutrition, Immunology and Epidemiology of Tuberculosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard School of Public Health:

Primary Outcome Measures:
  • To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse and reinfection. [ Time Frame: Sputum and culture negativity: 1 month and 2 months; Survival: 8 months and 24 months; TB relapse and reinfection: throughout follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters. [ Time Frame: 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. ] [ Designated as safety issue: No ]

Enrollment: 876
Study Start Date: March 2000
Study Completion Date: May 2004
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Other: Placebo
Placebo pill taken orally on a daily basis from the start of TB therapy through 8 months of anti-TB therapy
Experimental: 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
 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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197704

Locations
United States, Massachusetts
Harvard School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Wafaie W Fawzi, MD,DrPh Harvard School of Public Health
  More Information

Publications:

Responsible Party: Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197704     History of Changes
Other Study ID Numbers: AI45441
Study First Received: September 12, 2005
Last Updated: November 9, 2010
Health Authority: United States: Institutional Review Board
Tanzania: National Institute for Medical Research

Keywords provided by Harvard School of Public Health:
Tuberculosis
HIV
Tanzania
multivitamins

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on March 03, 2013