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Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

NCT00610688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2021-10-19

Study results available
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Summary

The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

Prenatal Vitamin

Once daily, prenatal vitamin containing 400IU of Vitamin D, until delivery

DRUG

Cholecalciferol (Vitamin D3)

Once daily, 1600IU dose of Vitamin D from 12 weeks gestation to delivery

DRUG

Cholecalciferol (Vitamin D3)

Once daily, 3600IU dose of Vitamin D, from 12 weeks until delivery

Sponsors & Collaborators

  • United Arab Emirates University

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Adekunle Dawodu, MBBS · Children's Hospital Medical Center, Cincinnati

  • Hussein F Saadi, MD · United Arab Emirates University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-06-30
Completion
2012-04-30

Countries

  • United States
  • United Arab Emirates

Study Locations

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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 NCT00610688 on ClinicalTrials.gov