NCT02043223

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

2.8 years

First QC Date

December 5, 2013

Last Update Submit

September 20, 2016

Conditions

Vitamin A Deficiency

Keywords

Vitamin ABreast milkPostpartum vitamin A supplementationInfant vaccine response

Outcome Measures

Primary Outcomes (1)

  • 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

    Four months

Secondary Outcomes (4)

  • Infant T helper cell immune responses

    Four months

  • Infant innate immune responses

    Four months

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

    Four months

  • Relative abundance of infant gut microbial community and gut inflammatory markers

    Four months

Other Outcomes (4)

  • Infant vitamin A status

    Four months

  • Infant growth

    Four months

  • Infant morbidity

    Four months

  • +1 more other outcomes

Study Arms (4)

Early postpartum vitamin A suppl.

EXPERIMENTAL

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

Dietary Supplement: Vitamin A (<3-day postpartum)

Late postpartum vitamin A suppl.

EXPERIMENTAL

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

Dietary Supplement: Vitamin A (6 wk postpartum)

Early & late postpartum vitamin A suppl

EXPERIMENTAL

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

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

No postpartum vitamin A suppl.

EXPERIMENTAL

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

Dietary Supplement: Placebo

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.

Early postpartum vitamin A suppl.
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.

Late postpartum vitamin A suppl.
Vitamin A (<3-day and 6 wk postpartum)DIETARY_SUPPLEMENT

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

Early & late postpartum vitamin A suppl
PlaceboDIETARY_SUPPLEMENT

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

No postpartum vitamin A suppl.

Eligibility Criteria

Age18 Years - 32 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant women \>-18 years of age with low-risk obstetric

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

  • 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.

    PMID: 25872802DERIVED

MeSH Terms

Conditions

Vitamin A Deficiency

Interventions

Vitamin APostpartum Period

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological FactorsReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Shaikh M Ahmad, Ph.D

    International Centre for Diarrhoeal Disease Research, Bangladesh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2013

First Posted

January 23, 2014

Study Start

October 1, 2013

Primary Completion

July 1, 2016

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

BA(1)