Vitamin D Supplementation in Breastfeeding Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01240265
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : April 30, 2013
Information provided by (Responsible Party):
Thomas Thacher, 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Rickets Infant Nutrition Disorders Dietary Supplement: Vitamin D3 Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : December 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: Cholecalciferol

Experimental: Vitamin D 5000 units daily
Vitamin D3 5000 IU daily given orally for 28 days
Dietary Supplement: Vitamin D3
5000 IU given orally daily for 28 days
Other Name: Cholecalciferol

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   1 Month to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01240265

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Thomas Thacher, MD Mayo Clinic

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Thacher, Consultant, Mayo Clinic Identifier: NCT01240265     History of Changes
Other Study ID Numbers: 10-004130
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: April 30, 2013
Last Verified: April 2013

Keywords provided by Thomas Thacher, Mayo Clinic:
Vitamin D deficiency

Additional relevant MeSH terms:
Vitamin D Deficiency
Nutrition Disorders
Infant Nutrition Disorders
Deficiency Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents