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Vitamin D Supplementation of Lactating Mothers

NCT01506557 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2013-07-23

No results posted yet for this study

Summary

The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.

The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.

Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.

Conditions

  • Vitamin D Deficiency

Interventions

DIETARY_SUPPLEMENT

cholecalciferol

dose 800 IU/day for 6 month

DIETARY_SUPPLEMENT

placebo

oil capsules

Sponsors & Collaborators

  • Nutricia Research Fundation

    collaborator OTHER

  • Children's Memorial Health Institute, Poland

    lead OTHER

Principal Investigators

  • Justyna Czech-Kowalska, MD, PhD · The Children's Memorial Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-10-31
Completion
2012-11-30

Countries

  • Poland

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 NCT01506557 on ClinicalTrials.gov