Vitamin D Supplementation of Lactating Mothers

Children's Memorial Health Institute, Poland174 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

174

Conditions

Vitamin D Deficiency

Interventions

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Public Hospital

Otwock, Warsaw, Poland

Anna Mazowiecka Hospital, Warsaw Medical University

Warsaw, Poland

Gynecological and Obstetric Hospital

Warsaw, Poland

The Children's Memorial Health Institute

Warsaw, Poland

Międzyleski Hospital,

Warsaw, Poland

Outcomes

Primary Outcomes

serum 25-hydroxyvitamin D concentration,

Time frame: 3 time poits up to 6 months (0-3-6 months)

Secondary Outcomes

body composition measured by dual x-ray densitometry

Time frame: 3 time points up to 6 months (0-3-6months)

serum calcium

Time frame: 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)

iPTH

Time frame: 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)

Prevalence of vitamin D sufficiency (25OHD>30ng/ml)

Time frame: 3 time poits up to 6 months (0-3-6 months)