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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

November 10, 2010
April 26, 2013
December 2010
August 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01240265 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Vitamin D Supplementation in Breastfeeding Women
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Vitamin D Deficiency
  • Rickets
  • Infant Nutrition Disorders
  • Dietary Supplement: Vitamin D3
    150,000 IU orally given once
    Other Name: Cholecalciferol
  • Dietary Supplement: Vitamin D3
    5000 IU given orally daily for 28 days
    Other Name: Cholecalciferol
  • Experimental: Vitamin D 150,000 units once
    Single dose of vitamin D3 150,000 IU given orally once
    Intervention: Dietary Supplement: Vitamin D3
  • Experimental: Vitamin D 5000 units daily
    Vitamin D3 5000 IU daily given orally for 28 days
    Intervention: Dietary Supplement: Vitamin D3
Oberhelman SS, Meekins ME, Fischer PR, Lee BR, Singh RJ, Cha SS, Gardner BM, Pettifor JM, Croghan IT, Thacher TD. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1378-87. doi: 10.1016/j.mayocp.2013.09.012.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
1 Month to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01240265
10-004130
No
Thomas Thacher, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Thomas Thacher, MD Mayo Clinic
Mayo Clinic
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP