Vitamin D Supplementation of Lactating Mothers (MAVID)

July 22, 2013 updated by: Justyna Czech-Kowalska, Children's Memorial Health Institute, Poland

Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 04-730
        • The Children's Memorial Health Institute
      • Warsaw, Poland, 00-315
        • Anna Mazowiecka Hospital, Warsaw Medical University
      • Warsaw, Poland, 02-544
        • Gynecological and Obstetric Hospital
      • Warsaw, Poland, 04-749
        • Międzyleski Hospital,
    • Warsaw
      • Otwock, Warsaw, Poland, 05-400
        • Public Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem

Exclusion Criteria:

  • Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
  • Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Dietary supplement: placebo
oil capsules
Experimental: choecalciferol
Dietary supplement: cholecalciferol
dose 800 IU/day for 6 month
Other Names:
  • vit D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum 25-hydroxyvitamin D concentration,
Time Frame: 3 time poits up to 6 months (0-3-6 months)
3 time poits up to 6 months (0-3-6 months)

Secondary Outcome Measures

Outcome Measure
Time Frame
body composition measured by dual x-ray densitometry
Time Frame: 3 time points up to 6 months (0-3-6months)
3 time points up to 6 months (0-3-6months)
serum calcium
Time Frame: 2 time poits up to 6 months ( 3-6 months)
2 time poits up to 6 months ( 3-6 months)
calciuria (Urinary calcium and creatinine - UCa/crea)
Time Frame: 2 time poits up to 6 months ( 3-6 months)
2 time poits up to 6 months ( 3-6 months)
iPTH
Time Frame: 3 time poits up to 6 months (0-3-6 months)
3 time poits up to 6 months (0-3-6 months)
Prevalence of vitamin D deficiency (25OHD<20ng/ml)
Time Frame: 3 time poits up to 6 months (0-3-6 months)
3 time poits up to 6 months (0-3-6 months)
Prevalence of vitamin D sufficiency (25OHD>30ng/ml)
Time Frame: 3 time poits up to 6 months (0-3-6 months)
3 time poits up to 6 months (0-3-6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Memorial Health Institute, Poland

Collaborators

Nutricia Research Fundation

Investigators

  • Principal Investigator: Justyna Czech-Kowalska, MD, PhD, The Children's Memorial Health Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 11, 2011

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 22, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 763/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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