Vitamin D Supplementation of Lactating Mothers

Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01506557

Acronym

MAVID

Enrollment

174

Registered

2012-01-10

Start date

2011-03-31

Completion date

2012-11-30

Last updated

2013-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

vitamin D, vitamin D deficiency, breastfeeding, body composition, bone mineral content

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.

Interventions

DIETARY_SUPPLEMENTcholecalciferol

dose 800 IU/day for 6 month

DIETARY_SUPPLEMENTplacebo

oil capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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)
body composition measured by dual x-ray densitometry	3 time points up to 6 months (0-3-6months)
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)
iPTH	3 time poits up to 6 months (0-3-6 months)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026