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Completed

NCT Number: NCT00197704

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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multivitamins

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

Placebo

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Nov 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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