Stopping Postpartum Vitamin A Supplementation: Missing Concealed Benefit

NCT ID: NCT02043223

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Brief Summary

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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

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The effect will be assessed by the milk and blood.

Conditions

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Vitamin A Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Early postpartum vitamin A suppl.

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

Group Type EXPERIMENTAL

Vitamin A (<3-day postpartum)

Intervention Type DIETARY_SUPPLEMENT

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

Late postpartum vitamin A suppl.

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

Group Type EXPERIMENTAL

Vitamin A (6 wk postpartum)

Intervention Type DIETARY_SUPPLEMENT

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

Early & late postpartum vitamin A suppl

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

No postpartum vitamin A suppl.

Placebo supplementation, both at \<3-day and 6-wk postpartum.

Group Type EXPERIMENTAL

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo supplementation, both at \<3-day and 6-wk postpartum.

Interventions

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Vitamin A (<3-day postpartum)

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

Intervention Type DIETARY_SUPPLEMENT

Vitamin A (6 wk postpartum)

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

Intervention Type DIETARY_SUPPLEMENT

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

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo supplementation, both at \<3-day and 6-wk postpartum.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

32 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Peter Bergman, MD, PhD

UNKNOWN

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaikh M Ahmad, Ph.D

Role: PRINCIPAL_INVESTIGATOR

International Centre for Diarrhoeal Disease Research, Bangladesh

Locations

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International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

References

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Ahmad SM, Hossain MI, Bergman P, Kabir Y, Raqib R. The effect of postpartum vitamin A supplementation on breast milk immune regulators and infant immune functions: study protocol of a randomized, controlled trial. Trials. 2015 Mar 31;16:129. doi: 10.1186/s13063-015-0654-9.

Reference Type DERIVED
PMID: 25872802 (View on PubMed)

Other Identifiers

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PR-13060

Identifier Type: -

Identifier Source: org_study_id

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