Vitamin D Supplementation of Lactating Mothers (MAVID)

Children's Memorial Health Institute, Poland

Status and phase

Completed

Phase 4

Conditions

Vitamin D Deficiency

Treatments

Dietary Supplement: placebo

Dietary Supplement: cholecalciferol

Study type

Interventional

Funder types

Other

Identifiers

NCT01506557

763/10

Details and patient eligibility

About

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.

Enrollment

174 patients

Sex

Female

Volunteers

Accepts Healthy Volunteers

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.