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Establishing the Vitamin D Requirements During Lactation

NCT00412074 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2018-06-04

Study results available
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Summary

The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

400 IU Vitamin D3 (cholecalciferol)

400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant

DRUG

2400 IU Vitamin D3 (cholecalciferol)

2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant

DRUG

6400 IU Vitamin D3 (cholecalciferol)

6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • 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, MD · Medical University of South Carolina

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-10-31
Completion
2012-10-31

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 NCT00412074 on ClinicalTrials.gov