Trial | NCT01506557  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    vitamin d3 ...

  • Study Participants

    174
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 Started
Mar 31
2011
Primary Completion
Oct 31
2012
Study Completion
Nov 30
2012
Last Update
Jul 23
2013
Estimate

Dietary Supplement cholecalciferol

dose 800 IU/day for 6 month

  • Other names: vit D

Dietary Supplement placebo

oil capsules

choecalciferol Experimental

placebo Placebo Comparator

Criteria 

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.
No Results Posted