Vitamin D Supplementation in Breastfeeding Women

Phase 2

Completed

• Conditions: Rickets; Vitamin D Deficiency; Infant Nutrition Disorders
• Interventions: Dietary Supplement: Vitamin D3

• Registration Number: NCT01240265
• Lead Sponsor: Mayo Clinic

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 Description

Not available

Study Timeline

• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-15
• Study Start: 2010-12
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-26
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D 5000 units daily	Vitamin D3	Vitamin D3 5000 IU daily given orally for 28 days
Vitamin D 150,000 units once	Vitamin D3	Single dose of vitamin D3 150,000 IU given orally once

Primary Outcome Measures

Name	Time	Method
The number of days of detectable milk vitamin D concentrations	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.

Secondary Outcome Measures

Name	Time	Method
Infant serum 25(OH)D concentration	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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States