Vitamin D Supplementation in Breastfeeding Women

April 26, 2013 updated by: Thomas Thacher, Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D 150,000 units once
Single dose of vitamin D3 150,000 IU given orally once
Dietary supplement: Vitamin D3
150,000 IU orally given once
Other Names:
  • Cholecalciferol
Dietary supplement: Vitamin D3
5000 IU given orally daily for 28 days
Other Names:
  • Cholecalciferol
Experimental: Vitamin D 5000 units daily
Vitamin D3 5000 IU daily given orally for 28 days
Dietary supplement: Vitamin D3
150,000 IU orally given once
Other Names:
  • Cholecalciferol
Dietary supplement: Vitamin D3
5000 IU given orally daily for 28 days
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Thomas Thacher, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimate)

November 15, 2010

Study Record Updates

Last Update Posted (Estimate)

April 30, 2013

Last Update Submitted That Met QC Criteria

April 26, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-004130

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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