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Effect of Maternal Vitamin D3 Supplementation on Iron Status During Pregnancy and Early Infancy

NCT04764955 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1300

Last updated 2023-06-18

No results posted yet for this study

Summary

This is a secondary-use study based on previously-collected data and blood samples from a previously completed double-blind, dose-ranging trial of maternal prenatal and postpartum vitamin D supplementation in Dhaka, Bangladesh (NCT01924013). The aim of this sub-study is to examine the effect of vitamin D supplementation on iron status during pregnancy and early infancy.

Conditions

  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

Placebo

This product is identical in appearance, taste and texture to the experimental formulation but does not include any vitamin D3.

DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol)

The intervention is an oral tablet containing vitamin D3 (cholecalciferol). Each weekly dose consists of a single tablet. Vitamin D3 content of the dose depends on the intervention group.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • King's College London

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Daniel E Roth, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2017-03-31
Completion
2018-03-31

Countries

  • Bangladesh

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764955 on ClinicalTrials.gov