Clinical Trials/NCT02043223

NCT02043223CompletedPhase 2

Stopping Postpartum Vitamin A Supplementation: Are we Missing Concealed Benefit?

International Centre for Diarrhoeal Disease Research, Bangladesh2 sites in 1 country160 target enrollmentStarted: October 2013Last updated: September 21, 2016

Conditions

Trial Snapshot

Phase: Phase 2
Status: Completed
Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Enrollment: 160
Locations: 2
Primary Endpoint: Breast milk immune regulators

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

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 Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 32 Years (Adult)
Sex: Female
Accepts Healthy Volunteers: Yes

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

Outcomes

Primary Outcomes

Breast milk immune regulators

Time Frame: 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 Outcomes

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

Investigators

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh

Sponsor Class

Other

Responsible Party

Sponsor

Study Sites (2)

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