Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

Phase 3CompletedNCT02043223

International Centre for Diarrhoeal Disease Research, Bangladesh160 enrolled

Overview

The purpose of this study is to evaluate the effect of post-partum maternal vitamin A supplementation on breast milk bioactive compounds and immune status, growth and morbidity of children in the first four months of life.

The effect will be assessed by the milk and blood.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

160

Conditions

Vitamin A Deficiency

Interventions

Vitamin A (<3-day postpartum)DIETARY_SUPPLEMENT

Single dose 200,000 IU vitamin A supplementation at \<3-day and placebo supplementation at 6-wk postpartum.

Vitamin A (6 wk postpartum)DIETARY_SUPPLEMENT

Placebo supplementation at \<3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.

Vitamin A (<3-day and 6 wk postpartum)DIETARY_SUPPLEMENT

200,000 IU vitamin A supplementation, both at \<3-day and 6-wk postpartum

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 32 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women \>-18 years of age with low-risk obstetric Exclusion Criteria: * Pregnant women expecting a multiple birth * Take vitamin A supplements during postpartum apart from study intervention * Premature birth * Newborn babies with birth defects and / or other serious diseases

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Outcomes

Primary Outcomes

Breast milk immune regulators

immune regulators in breast milk e.g. B-cell activating factor (BAFF); IL-7; Lactoferrin; sCD14, sIgA and TGF-beta levels at three time points- 1. \< 3-day postpartum (before 1st dose of supplementation) 2. 7 wk postpartum (1wk after 2nd dose of supplementation) 3. 15 wk postpartum

Time frame: Four months

Secondary Outcomes

Infant T helper cell immune responses

Mitogen stimulated whole blood IL-10, IL-13, IFN-gamma, IL-21 and IL-17 responses at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)

Time frame: Four months

Infant innate immune responses

Tall like receptor (TLR)-4 and TLR9 agonist stimulated whole blood TNF-alpha and IL-10 and IFN-alpha responses at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)

Time frame: Four months

Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses

Hepatitis B and Tetanus Toxoid specific plasma cell IgG responses at 15 wk of age (1wk after three doses of pentavalent vaccination) And Hepatitis B and Tetanus Toxoid specific IgG in plasma and Polio (3 serotypes) specific secretory IgA (sIgA) in stool at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)

Time frame: Four months

Relative abundance of infant gut microbial community and gut inflammatory markers

Next generation sequencing (NGS) of bacterial 16s rDNA (+qPCR) in extracted stool samples and assessment of infant gut inflammatory markers e.g. human β-defensin-2 (HBD2); Neopterin; α-1-antitrypsin (AAT); neutrophil gelatinase-associated lipocalin (NGAL)-2 and S100A at two time points- 1. 7 wk of age (1wk after 2nd dose of maternal supplementation , as well as, 1wk after first doses of pentavalent vaccination) 2. 15 wk of age (1wk after three doses of pentavalent vaccination)

Data from ClinicalTrials.gov

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