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Nutrition, Immunology and Epidemiology of Tuberculosis

P

President and Fellows of Harvard College

Status and phase

Completed
Phase 3

Conditions

Tuberculosis

Treatments

Other: Placebo
Dietary Supplement: Multivitamins

Study type

Interventional

Funder types

Other

Identifiers

NCT00197704
AI45441

Details and patient eligibility

About

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

Full 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.

Enrollment

876 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

876 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Other: Placebo
Multivitamins
Experimental group
Description:
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
Treatment:
Dietary Supplement: Multivitamins

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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