Status:
COMPLETED
Vitamin D Supplementation in Breastfeeding Women
Lead Sponsor:
Mayo Clinic
Conditions:
Vitamin D Deficiency
Rickets
Eligibility:
All Genders
1-50 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01240265
Start Date
December 1 2010
End Date
August 1 2011
Last Update
April 30 2013
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905