title: The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02043223 , 5 December 2013.
authors: Center for Vaccine Sciences, icddr,b, Mohakhali, Dhaka, 1212, Bangladesh. smeahmad@icddrb.org.
authors: Shaikh Meshbahuddin
authors: SM
authors: Ahmad
authors: Center for Nutrition and Food Security, icddr,b, Mohakhali, Dhaka, 1212, Bangladesh. ihossain@icddrb.org.
authors: Md Iqbal
authors: MI
authors: Hossain
authors: Karolinska University Hospital, Huddinge, S-141 86, Stockholm, Sweden. Peter.Bergman@ki.se.
authors: Peter
authors: P
authors: Bergman
authors: Department of Biochemistry and Molecular Biology, University of Dhaka, Dhaka, 1000, Bangladesh. ykabir@yahoo.com.
authors: Yearul
authors: Y
authors: Kabir
authors: Center for Vaccine Sciences, icddr,b, Mohakhali, Dhaka, 1212, Bangladesh. rubhana@icddrb.org.
authors: Rubhana
authors: R
authors: Raqib
mesh_terms: D019587:Dietary Supplements; D005260:Female; D006801:Humans; D007223:Infant; D008895:Milk, Human / Q000276:immunology*; D011181:Postnatal Care; D014801:Vitamin A / Q000008:administration & dosage*; D014815:Vitamins / Q000008:administration & dosage*
chemical_list: D014815:Vitamins; D014801:Vitamin A