Clinical trial NCT01506557: Vitamin D Supplementation of Lactating Mothers
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: vitamin D
vitamin D deficiency
breastfeeding
body composition
bone mineral content
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
Collaborators: name: Nutricia Research Fundation
First posted: 2012-01-10
Enrollment: 174
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: serum 25-hydroxyvitamin D concentration,
timeFrame: 3 time poits up to 6 months (0-3-6 months)
Secondary outcomes:
measure: body composition measured by dual x-ray densitometry
timeFrame: 3 time points up to 6 months (0-3-6months)
measure: serum calcium
timeFrame: 2 time poits up to 6 months ( 3-6 months)
measure: calciuria (Urinary calcium and creatinine - UCa/crea)
timeFrame: 2 time poits up to 6 months ( 3-6 months)
measure: iPTH
timeFrame: 3 time poits up to 6 months (0-3-6 months)
measure: Prevalence of vitamin D deficiency (25OHD<20ng/ml)
timeFrame: 3 time poits up to 6 months (0-3-6 months)
measure: Prevalence of vitamin D sufficiency (25OHD>30ng/ml)
timeFrame: 3 time poits up to 6 months (0-3-6 months)
Other outcomes:
Locations:
city: Otwock
country: Poland
facility: Public Hospital
state: Warsaw
city: Warsaw
country: Poland
facility: Anna Mazowiecka Hospital, Warsaw Medical University
city: Warsaw
country: Poland
facility: Gynecological and Obstetric Hospital
city: Warsaw
country: Poland
facility: The Children's Memorial Health Institute
city: Warsaw
country: Poland
facility: Międzyleski Hospital,
Study officials:
affiliation: The Children's Memorial Health Institute
name: Justyna Czech-Kowalska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.