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Maternal Vit D Supplements & Infant and Maternal Biomarkers & Outcomes in Southern Ethiopia

NCT02210884 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2017-02-06

No results posted yet for this study

Summary

Synthesis of vitamin D in the skin through the action of sunlight is a major source of vitamin D in parts of the world where foods are not fortified with the vitamin. Skin pigmentation (color), dress habits and season are some of the factors that limit sun exposure and affect vitamin D synthesis in the skin. Maternal vitamin D status is especially important to meet infant needs when newborns are not supplemented with vitamin D. In Ethiopia, vitamin D status of lactating women and infants and breast milk vitamin D concentration have never been assessed. The purpose of this study is to assess changes in maternal and infant markers of vitamin D status before and after vitamin D supplementation of the lactating mothers.

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Weekly oral supplementation with 15,000 IU vitamin D

Sponsors & Collaborators

  • Oklahoma State University

    lead OTHER

Principal Investigators

  • Barbara J Stoecker, PhD · Oklahoma State University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Ethiopia

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 NCT02210884 on ClinicalTrials.gov