NCT01506557

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

1.6 years

First QC Date

May 11, 2011

Last Update Submit

July 22, 2013

Conditions

Vitamin D Deficiency

Keywords

vitamin Dvitamin D deficiencybreastfeedingbody compositionbone mineral content

Outcome Measures

Primary Outcomes (1)

  • serum 25-hydroxyvitamin D concentration,

    3 time poits up to 6 months (0-3-6 months)

Secondary Outcomes (6)

  • body composition measured by dual x-ray densitometry

    3 time points up to 6 months (0-3-6months)

  • serum calcium

    2 time poits up to 6 months ( 3-6 months)

  • calciuria (Urinary calcium and creatinine - UCa/crea)

    2 time poits up to 6 months ( 3-6 months)

  • iPTH

    3 time poits up to 6 months (0-3-6 months)

  • Prevalence of vitamin D deficiency (25OHD<20ng/ml)

    3 time poits up to 6 months (0-3-6 months)

  • +1 more secondary outcomes

Study Arms (2)

choecalciferol

EXPERIMENTAL
Dietary Supplement: cholecalciferol

placebo

PLACEBO COMPARATOR
Dietary Supplement: placebo

Interventions

cholecalciferolDIETARY_SUPPLEMENT

dose 800 IU/day for 6 month

Also known as: vit D
choecalciferol
placeboDIETARY_SUPPLEMENT

oil capsules

placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Public Hospital

Otwock, Warsaw, 05-400, Poland

Location

Anna Mazowiecka Hospital, Warsaw Medical University

Warsaw, 00-315, Poland

Location

Gynecological and Obstetric Hospital

Warsaw, 02-544, Poland

Location

The Children's Memorial Health Institute

Warsaw, 04-730, Poland

Location

Międzyleski Hospital,

Warsaw, 04-749, Poland

Location

Related Publications (1)

  • 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.

    PMID: 25232839DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyBreast Feeding

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Justyna Czech-Kowalska, MD, PhD

    The Children's Memorial Health Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Head of Neonatology and Intensive Care, MD, PhD

Study Record Dates

First Submitted

May 11, 2011

First Posted

January 10, 2012

Study Start

March 1, 2011

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

PL(5)