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Vitamin D Supplementation of Lactating Mothers (MAVID)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
cholecalciferol
placebo
Sponsored by
Children's Memorial Health Institute, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring vitamin D, vitamin D deficiency, breastfeeding, body composition, bone mineral content

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Public Hospital
  • Anna Mazowiecka Hospital, Warsaw Medical University
  • Gynecological and Obstetric Hospital
  • The Children's Memorial Health Institute
  • Międzyleski Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

choecalciferol

placebo

Arm Description

Outcomes

Primary Outcome Measures

serum 25-hydroxyvitamin D concentration,

Secondary Outcome Measures

body composition measured by dual x-ray densitometry
serum calcium
calciuria (Urinary calcium and creatinine - UCa/crea)
iPTH
Prevalence of vitamin D deficiency (25OHD<20ng/ml)
Prevalence of vitamin D sufficiency (25OHD>30ng/ml)

Full Information

First Posted
May 11, 2011
Last Updated
July 22, 2013
Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Nutricia Research Fundation
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1. Study Identification

Unique Protocol Identification Number
NCT01506557
Brief Title
Vitamin D Supplementation of Lactating Mothers
Acronym
MAVID
Official Title
Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Nutricia Research Fundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
vitamin D, vitamin D deficiency, breastfeeding, body composition, bone mineral content

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
choecalciferol
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vit D
Intervention Description
dose 800 IU/day for 6 month
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
oil capsules
Primary Outcome Measure Information:
Title
serum 25-hydroxyvitamin D concentration,
Time Frame
3 time poits up to 6 months (0-3-6 months)
Secondary Outcome Measure Information:
Title
body composition measured by dual x-ray densitometry
Time Frame
3 time points up to 6 months (0-3-6months)
Title
serum calcium
Time Frame
2 time poits up to 6 months ( 3-6 months)
Title
calciuria (Urinary calcium and creatinine - UCa/crea)
Time Frame
2 time poits up to 6 months ( 3-6 months)
Title
iPTH
Time Frame
3 time poits up to 6 months (0-3-6 months)
Title
Prevalence of vitamin D deficiency (25OHD<20ng/ml)
Time Frame
3 time poits up to 6 months (0-3-6 months)
Title
Prevalence of vitamin D sufficiency (25OHD>30ng/ml)
Time Frame
3 time poits up to 6 months (0-3-6 months)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justyna Czech-Kowalska, MD, PhD
Organizational Affiliation
The Children's Memorial Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Hospital
City
Otwock
State/Province
Warsaw
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Anna Mazowiecka Hospital, Warsaw Medical University
City
Warsaw
ZIP/Postal Code
00-315
Country
Poland
Facility Name
Gynecological and Obstetric Hospital
City
Warsaw
ZIP/Postal Code
02-544
Country
Poland
Facility Name
The Children's Memorial Health Institute
City
Warsaw
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Międzyleski Hospital,
City
Warsaw
ZIP/Postal Code
04-749
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
25232839
Citation
Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, Chazan B, Pawlus B, Zochowska A, Borszewska-Kornacka MK, Karczmarewicz E, Czekuc-Kryskiewicz E, Dobrzanska A. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLoS One. 2014 Sep 18;9(9):e107708. doi: 10.1371/journal.pone.0107708. eCollection 2014.
Results Reference
derived

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Vitamin D Supplementation of Lactating Mothers

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