Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

Phase 2

Completed

• Conditions: Vitamin A Deficiency
• Interventions: Dietary Supplement: Vitamin A (<3-day and 6 wk postpartum); Dietary Supplement: Placebo; Dietary Supplement: Vitamin A (<3-day postpartum); Dietary Supplement: Vitamin A (6 wk postpartum)

• Registration Number: NCT02043223
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary

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.

Detailed Description

The effect will be assessed by the milk and blood.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2014-01-19
• Study First Posted: 2014-01-23
• Primary Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early & late postpartum vitamin A suppl	Vitamin A (<3-day and 6 wk postpartum)	200,000 IU vitamin A supplementation, both at \<3-day and 6-wk postpartum
No postpartum vitamin A suppl.	Placebo	Placebo supplementation, both at \<3-day and 6-wk postpartum.
Early postpartum vitamin A suppl.	Vitamin A (<3-day postpartum)	Single dose 200,000 IU vitamin A supplementation at \<3-day and placebo supplementation at 6-wk postpartum.
Late postpartum vitamin A suppl.	Vitamin A (6 wk postpartum)	Placebo supplementation at \<3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.

Primary Outcome Measures

Name	Time	Method
Breast milk immune regulators	Four months	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

Secondary Outcome Measures

Name	Time	Method
Infant T helper cell immune responses	Four months	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)
Infant vaccines (Hepatitis B, Tetanus and Oral polio) specific antibody responses	Four months	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)
Infant innate immune responses	Four months	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)
Relative abundance of infant gut microbial community and gut inflammatory markers	Four months	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)

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh