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Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

Information source: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vitamin A Deficiency

Intervention: Vitamin A (<3-day postpartum) (Dietary Supplement); Vitamin A (6 wk postpartum) (Dietary Supplement); Vitamin A (<3-day and 6 wk postpartum) (Dietary Supplement); Placebo (Dietary Supplement)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: International Centre for Diarrhoeal Disease Research, Bangladesh

Official(s) and/or principal investigator(s):
Shaikh M Ahmad, Ph.D, Principal Investigator, Affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh

Overall contact:
Shaikh M Ahmad, Ph.D, Phone: +88029827001-10, Ext: 3469, Email: smeahmad@icddrb.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Breast milk TGF-beta

Breast milk secretory IgA (sIgA)

Secondary outcome:

Infant T helper cell immune responses

Infant innate immune responses

Detailed description: The effect will be assessed by the milk and blood.

Eligibility

Minimum age: 18 Years. Maximum age: 32 Years. Gender(s): Female.

Criteria:

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 and Contacts

Shaikh M Ahmad, Ph.D, Phone: +88029827001-10, Ext: 3469, Email: smeahmad@icddrb.org

International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh; Recruiting
Shaikh M Ahmad, Ph.D, Phone: +88029827001-10, Ext: 3469, Email: smeahmad@icddrb.org
Raqib Rubhana, Ph.D, Phone: +88029827001-10, Ext: 2404, Email: rubhana@icddrb.org
Shaikh M Ahmad, Ph.D, Principal Investigator
Additional Information

Starting date: October 2013
Last updated: July 26, 2015

Page last updated: August 23, 2015

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