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Efficacy of Newborn Vitamin A Supplementation in Improving Immune Function

NCT01583972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-08-26

No results posted yet for this study

Summary

Vitamin A supplementation at birth may increase survival of infants through one year of age by reducing mortality from infectious diseases, though current studies are not conclusive on this point. The goal of our study is to determine if supplementation of newborn infants with 50,000 IU of vitamin A improves aspects of immune function that may be impaired by vitamin A deficiency. Our underlying assumption is that supplementation may thus decrease risk of death by improving immune function and the ability to survive infections. This project will be limited to the examination of the impact of vitamin A on immune function and will not aim to determine the impact on morbidity or mortality, which would require larger sample sizes. The hypotheses addressed by this study are as follows: Provision of vitamin A supplements to newborns at risk of vitamin A deficiency will (1) improve functioning of the thymus (the source of T lymphocytes, cells of the immune system that are important in response to infection and immunization); (2) enhance T lymphocyte-mediated responses to standard vaccines given at birth and early in infancy; and (3) improve gut barrier function (i.e., ability to prevent bacterial infection across the epithelial barrier), relative to provision of a placebo.

Conditions

  • Vitamin A Deficiency

Interventions

DIETARY_SUPPLEMENT

retinyl palmitate

50,000 IU vitamin A in oil given within 48 h of birth from single-dose capsule

DIETARY_SUPPLEMENT

Placebo

edible oil used as diluent for vitamin A given within 48 h of birth from single-dose capsule identical in appearance to vitamin A capsule

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • World Health Organization

    collaborator OTHER

  • USDA, Western Human Nutrition Research Center

    lead FED

Principal Investigators

  • Charles B. Stephensen, Ph.D. · USDA, Western Human Nutrition Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-07-31
Completion
2014-08-31

Countries

  • Bangladesh

Study Locations

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Companies

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 NCT01583972 on ClinicalTrials.gov