Vitamin D Supplementation in Breastfeeding Women

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This study has been completed

Inclusion criteria

Currently lactating mothers at least 18 years of age
Willing to continue exclusively breastfeeding their infant throughout the study interval
The infant is 1-6 months of age at the beginning of the study
Willing and able to participate in all aspects of the study
Mother and infant are in good health, as determined by the study investigator
Have been provided with, understand, and have signed the informed consent for themselves and their child.

Exclusion criteria

Have recently travelled (within the preceding 30 days) or plan to travel south of 35 degrees north latitude during the study interval
Have recently or plan to engage in indoor tanning
Are currently taking medications that affect vitamin D metabolism, like steroids, anticonvulsants, or barbiturates
Are nursing multiple infants (e.g. twins)
Are taking greater than the daily recommended intake of 1000 mg elemental calcium as calcium supplements
Are taking greater than the standard daily dose of 400 IU of vitamin D found in prenatal vitamins
Infant weight below 1.67 kg
Mothers with baseline 25(OH)D levels >70 ng/ml, and/or infants with baseline 25(OH)D levels >70 ng/ml
History of kidney stones

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Thomas Thacher, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Thacher, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

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