Vitamin D Supplementation of Lactating Mothers

Phase 4

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: cholecalciferol; Dietary Supplement: placebo

• Registration Number: NCT01506557
• Lead Sponsor: Children's Memorial Health Institute, Poland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-22
• Last Update Posted: 2013-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
choecalciferol	cholecalciferol	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
serum 25-hydroxyvitamin D concentration,	3 time poits up to 6 months (0-3-6 months)

Secondary Outcome Measures

Name	Time	Method
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)
Prevalence of vitamin D sufficiency (25OHD>30ng/ml)	3 time poits up to 6 months (0-3-6 months)

Trial Locations

Locations (5)

Gynecological and Obstetric Hospital; 🇵🇱 Warsaw, Poland

The Children's Memorial Health Institute; 🇵🇱 Warsaw, Poland

Anna Mazowiecka Hospital, Warsaw Medical University; 🇵🇱 Warsaw, Poland

Public Hospital; 🇵🇱 Otwock, Warsaw, Poland

Międzyleski Hospital,; 🇵🇱 Warsaw, Poland