Status:
COMPLETED
Establishing the Vitamin D Requirements During Lactation
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Vitamin D Deficiency
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficienc...
Detailed Description
Mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitD3. Mothers, lactating or nonlactating controls will be randomized to either Group A: s...
Eligibility Criteria
Inclusion
- Mother plans to breastfeed exclusively for at least six months
- Mother is in good health
- Infant is 35 weeks' gestation or greater
- Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).
Exclusion
- Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months
- Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours
- Infant is less than 35 weeks' gestation
- Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern
- Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal
- Mother has history of hypercalciuria
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT00412074
Start Date
August 1 2006
End Date
October 1 2012
Last Update
June 4 2018
Active Locations (2)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425