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/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.

Figure 1

Study flow chart. ^aAccording to the national Expanded Program for Immunization (EPI) for newborn and infants. OPV, oral poliovirus vaccine; PENTA, pentavalent vaccines- a combination of five vaccines that comprise diphtheria, tetanus, whole cell pertussis, hepatitis B and haemophilus influenzae type b conjugate. ^bBased on maternal supplementations (Study interventions): Group 1: 200,000 IU VA at <3 d and placebo at 6 wk; Group 2: placebo at <3 d and 200,000 IU VA at 6-wk; Group 3: 200,000 IU VA, both at <3 d and 6 wk; and Group 4: placebo, both at <3 d and 6 wk.