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

September 12, 2005
November 9, 2010
March 2000
May 2004   (final data collection date for primary outcome measure)
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 ]
To determine the efficacy of micronutrient supplements on sputum conversion, survival, and TB relapse.
Complete list of historical versions of study NCT00197704 on ClinicalTrials.gov Archive Site
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 ]
To examine the effect of micronutrient supplements on HIV viral load, CD4 counts, body weight and immunological parameters.
Not Provided
Not Provided
 
Nutrition, Immunology and Epidemiology of Tuberculosis
Nutrition, Immunology and Epidemiology of Tuberculosis

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Tuberculosis
  • 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
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Other: Placebo
  • 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
    Intervention: Dietary Supplement: Multivitamins
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
876
May 2004
May 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00197704
AI45441
Yes
Wafaie Fawzi, Harvard School of Public Health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Wafaie W Fawzi, MD,DrPh Harvard School of Public Health
Harvard School of Public Health
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP