Establishing the Vitamin D Requirements During Lactation
Completed · Phase 3 · Has a placebo group
Conditions studied: Vitamin D Deficiency
In brief
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 deficiency in the breastfeeding mother-infant pair. The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant
Key facts
- Study ID
- NCT00412074
- Run by
- Medical University of South Carolina
- People needed
- 460
- Starts
- 2006-08-01
- Expected to finish
- 2012-10-01
- Last updated by the study team
- 2018-06-04
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
Full record on ClinicalTrials.gov
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