Clinical Trial: Vitamin D Supplementation in Breastfeeding Women

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum

Brief Summary: Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.

Detailed Summary:
Sponsor: Mayo Clinic

Current Primary Outcome: The number of days of detectable milk vitamin D concentrations [ Time Frame: 28 days ]

To compare the number of days of detectable milk vitamin D concentrations and incremental area under the curve between two dosing regimens of oral cholecalciferol in lactating mothers.


Original Primary Outcome: Same as current

Current Secondary Outcome: Infant serum 25(OH)D concentration [ Time Frame: 28 days ]

To compare the change in serum 25(OH)D concentrations in infants receiving milk from mothers supplemented with either 5,000 IU daily or 150,000 IU monthly cholecalciferol


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: November 10, 2010
Date Started: December 2010
Date Completion:
Last Updated: April 26, 2013
Last Verified: April 2013