This trial is active, not recruiting.

Condition vitamin d deficiency
Treatments vitamin d3 (cholecalciferol)
Phase phase 3
Sponsor Medical University of South Carolina
Collaborator National Institutes of Health (NIH)
Start date August 2006
End date October 2012
Trial size 556 participants
Trial identifier NCT00412074, HD047511, R01HD047511


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad
vitamin d3 (cholecalciferol)
400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant
6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant
vitamin d3 (cholecalciferol)
6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant

Primary Outcomes

25(OH)D levels for postpartum mother and the breastfeeding infant following for 7 months after delivery; bone mineral density of both mother and infant
time frame: to 7 months postpartum

Secondary Outcomes

maternal health status
time frame: to 7 months postpartum
infant health status
time frame: to 7 months of age

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Establishing the Vitamin D Requirements During Lactation
Principal investigator Bruce W. Hollis, Ph.D
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: standard treatment(400 IU D3/d), Group B: (2,400 IU D3/d), or Group C: (6,400 IU D3/d. Infants of mothers randomized to Group A will receive 400 IU D3/d (recommended practice) and infants of mothers assigned to Groups B or C will receive placebo. By measuring an array of indicators,calcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored. Through this study, the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 will be assessed.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.