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

NCT00558480 | Withdrawn

• 1 other identifier: SCC 1066
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Measurement of cytokine (IFN-gamma, IL-10, TNF-alpha, TGF-beta) levels produced in response to M. tb.

  2 years

Secondary Outcomes (3)

• FoxP3 gene expression with RT-PCR on mRNA from PBMCs.

  2 years

• Incidence of probable/confirmed TB; change in weight (mean weight gain)

  2 years

• Qualitative (positive/negative) and quantitative (mean change in counts) reversion of the T-cell assay

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Vitamin A

Drug: Vitamin A

2

PLACEBO COMPARATOR

Vitamin A placebo

Drug: Vitamin A placebo

Interventions

Vitamin A DRUG

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

Also known as: Retinol Palmitate

1

Vitamin A placebo DRUG

Vitamin A placebo at enrollment, 3 and 6 months

2

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Department of State for Health and Social Welfare, The Gambia: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Vitamin A; retinol palmitate

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Ifedayo MO Adetifa, MD FWACP

  MRC (UK) Laboratories, The Gambia

  PRINCIPAL INVESTIGATOR

• Martin OC Ota, MD FWACP PhD

  MRC (UK) Laboratories, The Gambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2012
• Last Updated: April 9, 2015

Record last verified: 2015-04