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Completed

NCT Number: NCT01240265

Vitamin D Supplementation in Breastfeeding Women

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Bone Diseases Bone Diseases, Metabolic Calcium Metabolism Disorders Deficiency Diseases Infant Nutrition Disorders Malnutrition Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Rickets

Age range

1 month–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

150,000 IU orally given once

Other names: Cholecalciferol

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 15, 2010
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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