Vitamin D Supplementation in Breastfeeding Women

Vitamin D Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01240265
• Other study ID #: 10-004130
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 10, 2010
• Last updated: April 26, 2013
• Start date: December 2010
• Est. completion date: August 2011

Study information

• Verified date: April 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Month to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infant Nutrition Disorders
• Nutrition Disorders
• Rickets
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
150,000 IU orally given once
• Vitamin D3
5000 IU given orally daily for 28 days

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of days of detectable milk vitamin D concentrations	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.	28 days	No
Secondary	Infant serum 25(OH)D concentration	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	28 days	Yes