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Evaluation of Vitamin D Requirements During Pregnancy

NCT00292591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2016-09-19

Study results available
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Summary

The purpose of this study is to determine the effectiveness of vitamin D supplementation during pregnancy starting at the beginning of the second trimester. Mothers will be randomized to one of three vitamin D dosing groups: 400, 2,000 or 4,000 international units per day. It is hypothesized that the highest dosing regimen will result in a better vitamin D status of women regardless of their ethnicity or race.

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

cholecalciferol (vitamin D3)

randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day

DRUG

cholecalciferol

comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Bruce W. Hollis, Ph.D. · Medical University of South Carolina

  • Carol L. Wagner, M.D. · Medical University of South Carolina

  • Donna Johnson, M.D. · Medical University of South Carolina

  • Thomas C. Hulsey, Sc.D. · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • United States

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 NCT00292591 on ClinicalTrials.gov