Vitamin D Supplementation Enhances Immune Response to Bacille-Calmette-Guerin (BCG) Vaccination in Infants
NCT ID: NCT01288950
Last Updated: 2012-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2011-02-28
2012-07-31
Brief Summary
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Detailed Description
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Increasing data indicate that children with low vitamin D levels and specific genetic variants that lower functional levels of vitamin D are at increased risk for severe tuberculosis. Elegant studies investigating Mycobacterium tuberculosis (Mtb) infection have shown that mycobacteria are able to reside in endosomes within macrophages by preventing endosome-lysosome fusion; a critical step in autophagy, a cellular process used to recycle cytoplasmic organelles and proteins, and to degrade microbial organisms including Mtb. In-vitro studies have shown that vitamin D increases autophagy and triggers the production of antimicrobial peptides including cathelicidin. This leads to increased intracellular killing of Mtb and increased Mtb antigen presentation to the immune system. Anti-tuberculous vaccines that over-express Mtb antigens generate a stronger immune response than wild type BCG vaccine.
The investigators hypothesis is that a single oral dose of vitamin D3 (cholecalciferol) given to infants prior to BCG administration will enhance the immune response to vaccination through improved MHC class I and class II presentation of the vaccine.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Vitamin D3
Vitamin D3 (cholecalciferol)
A single oral dose of 50,000 IU of vitamin D3 (cholecalciferol) will be given prior to Bacille-Calmette-Guerin (BCG) vaccination
Placebo
No interventions assigned to this group
Interventions
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Vitamin D3 (cholecalciferol)
A single oral dose of 50,000 IU of vitamin D3 (cholecalciferol) will be given prior to Bacille-Calmette-Guerin (BCG) vaccination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Term, healthy infants eligible to receive the Bacille-Calmette- Guerin (BCG) vaccine
Exclusion Criteria
* Known maternal human immuno-deficiency virus (HIV) infection
* Maternal fever or chorio-amnionitis
* Maternal use of vitamin D, steroids or immuno-regulatory medications
* Household member with active tuberculosis
3 Days
ALL
Yes
Sponsors
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Thrasher Research Fund
OTHER
University of California, San Diego
OTHER
Responsible Party
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Amaran Moodley
Research Fellow
Principal Investigators
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Stephen Spector, MD
Role: STUDY_CHAIR
University of California, San Diego
Amaran Moodley, M.D
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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Tijuana General Hospital
Tijuana, Estado de Baja California, Mexico
Countries
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References
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Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Other Identifiers
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NR-0138
Identifier Type: -
Identifier Source: org_study_id