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

• Status: Withdrawn
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical Research Council Unit, The Gambia
• Collaborators: Department of State for Health and Social Welfare, The Gambia; European and Developing Countries Clinical Trials Partnership (EDCTP)
• Treatments: Retinol palmitate; Vitamin A; Vitamins

Criteria

Inclusion Criteria:

• Otherwise healthy children aged 5-14 years

• Resident in the Greater Banjul area

• Normal chest X-ray

• Mantoux result ≥ 10mm in the widest diameter

• Positive T-SPOT-TB

• Negative HIV antibody test

• Negative pregnancy test for 12-14 year-old females

Exclusion Criteria:

• History of previous TB or treatment for TB

• Clinical case TB

• Current participation in another clinical trial (except SCC 1041, 1034)

• Clinically significant history or evidence of skin disorders, allergy, immunodeficiency, organ-specific disorders causing immunodeficiency.

• Likelihood of travel away from the study area during or for the duration of the study.

• Chronic use (≥14 days) of any oral or systemic steroid or use of other immunosuppressive/ immunomodulating agents.