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Nutrition, Immunology and Epidemiology of Tuberculosis

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ClinicalTrials.gov Identifier: NCT00197704
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 11, 2010
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health

Study Description
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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

Condition or disease Intervention/treatment Phase
Tuberculosis Dietary Supplement: Multivitamins Other: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 876 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutrition, Immunology and Epidemiology of Tuberculosis
Study Start Date : March 2000
Actual Primary Completion Date : May 2004
Actual Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00197704


Locations
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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
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Principal Investigator: Wafaie W Fawzi, MD,DrPh Harvard School of Public Health
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wafaie Fawzi, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT00197704    
Other Study ID Numbers: AI45441
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010
Keywords provided by Harvard School of Public Health:
Tuberculosis
HIV
Tanzania
multivitamins
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections