NCT01506557

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Children's Memorial Health Institute, Poland · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	cholecalciferol	dose 800 IU/day for 6 month
DIETARY_SUPPLEMENT	placebo	oil capsules

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2012-01-10
• Last updated: 2013-07-23

Locations

5 sites across 1 country: Poland