NCT01349127

Trial to Assess Vitamin D Requirements in Lactating Women

Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: University College Cork · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to assess vitamin D requirements in lactating women and to ascertain whether vitamin D supplementation at levels sufficient to achieve defined thresholds of maternal serum 25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will also report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and describe the relationship between them. Information on maternal iPTH levels, anthropometry, diet and sun exposure will also be reported.

Conditions

• Vitamin D Deficiency
• Vitamin D Insufficiency

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	20µg Vitamin D3	20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.
DIETARY_SUPPLEMENT	20µg Vitamin D3 + 500 mg Calcium	20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.
DIETARY_SUPPLEMENT	Placebo	One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2011-05-06
• Last updated: 2017-05-04

Locations

1 site across 1 country: Ireland