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Vitamin D Supplementation in Breastfeeding Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Thacher, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01240265
First received: November 10, 2010
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Vitamin D Deficiency
Rickets
Infant Nutrition Disorders
Dietary Supplement: Vitamin D3
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The number of days of detectable milk vitamin D concentrations [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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:
  • Infant serum 25(OH)D concentration [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    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


Enrollment: 80
Study Start Date: December 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01240265

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

No publications provided by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Thacher, Consultant, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01240265     History of Changes
Other Study ID Numbers: 10-004130
Study First Received: November 10, 2010
Last Updated: April 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Vitamin D deficiency
Rickets
Infant
Nutrition

Additional relevant MeSH terms:
Infant Nutrition Disorders
Malnutrition
Nutrition Disorders
Rickets
Vitamin D Deficiency
Avitaminosis
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Metabolic Diseases
Musculoskeletal Diseases
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014