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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial

Authors: Shaikh Meshbahuddin Ahmad, Md Iqbal Hossain, Peter Bergman, Yearul Kabir, Rubhana Raqib

Published in: Trials | Issue 1/2015

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Abstract

Background

Because of limited impact on infant morbidity, mortality, and vitamin A status, the new guideline of the World Health Organization (WHO) does not recommend postpartum vitamin A supplementation (VAS) as a public health intervention in developing countries. However, breast milk contains numerous immune-protective components that are important for infant immune development, and several of these components are regulated by vitamin A.

Methods/design

Postpartum women are being enrolled within 3 days (d) of delivery at a maternity clinic located in a slum area of Dhaka city and randomized to one of four postpartum VAS regimens (32/group, total 128). The regimens are as follows: Group 1: 200,000 IU VAS at <3 d and placebo at 6 weeks postpartum; Group 2: placebo at <3 d and 200,000 IU VAS at 6 weeks postpartum; Group 3: 200,000 IU VAS, both at <3 d and 6 weeks postpartum; Group 4: placebo, both at <3 d and 6 weeks postpartum. Breast milk samples at <3 d (before supplementation) and 4 months postpartum will be used to measure vitamin A and bioactive compounds. Infant blood samples at 2 and 4 months of age will be used to measure vitamin A, as well as innate and vaccine-specific immune responses. Dietary, anthropometric, and morbidity data are also being collected.

Discussion

This is the first placebo-controlled randomized clinical trial of postnatal vitamin A supplementation to investigate the key bioactive compounds in breast milk, important for infant immunity, in relation to dose and time point of postpartum supplementation and whether such maternal supplementation improves infant immune status during the critical period of early infancy.

Trial registration

ClinicalTrials.gov: NCT02043223, 5 December 2013
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Metadata
Title
The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial
Authors
Shaikh Meshbahuddin Ahmad
Md Iqbal Hossain
Peter Bergman
Yearul Kabir
Rubhana Raqib
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0654-9

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