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Vitamin A Supplementation for Modulation of Mycobacterium Tuberculosis Immune Responses in Latent Tuberculosis

NCT00558480 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-04-09

No results posted yet for this study

Summary

In populations with high prevalence of latent tuberculosis infection (LTBI), malnutrition (PEM) may influence incident rates of TB. PEM and specific micronutrient deficiencies compromise cell mediated immunity (CMI) and increase susceptibility to, or severity of infections. Vitamin A supplementation significantly reduces all-cause child mortality. The mechanism of the benefits of supplementation on clinical outcomes is largely unknown, but is likely to be related to an influence on the immune system. Vitamin A supplementation promotes lymphogenesis and induces a higher proportion of CD4 naïve T-cells in children. Most cases of LTBI that progress to active disease are vitamin A deficient. Vitamin A deficiency is common in most TB endemic countries. At the MRC, 32% of TBCC contacts were vitamin A deficient.

Hypothesis:

The investigators plan to test the hypotheses: that supplementation with vitamin A will affect the magnitude and quality of immune responses to mycobacterial antigens and progression to clinical disease.

Conditions

  • Latent Tuberculosis Infection

Interventions

DRUG

Vitamin A

Vitamin A capsules, as retinol palmitate 200,000 IU at enrollment, 3 and 6 months

DRUG

Vitamin A placebo

Vitamin A placebo at enrollment, 3 and 6 months

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Department of State for Health and Social Welfare, The Gambia

    collaborator OTHER_GOV

  • Medical Research Council Unit, The Gambia

    lead OTHER

Principal Investigators

  • Ifedayo MO Adetifa, MD FWACP · MRC (UK) Laboratories, The Gambia

  • Martin OC Ota, MD FWACP PhD · MRC (UK) Laboratories, The Gambia

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-07-31
Completion
2012-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00558480 on ClinicalTrials.gov