Establishing the Vitamin D Requirements During Lactation

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

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 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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