Phase 3
N=460
Establishing the Vitamin D Requirements During Lactation
Vitamin D Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00412074 ↗Enrolled (actual)
460
Serious AEs
0.7%
Results posted
Jun 2016
Primary outcome: Primary: 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery — 28.5; 38.0; 55.6 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 400 IU Vitamin D3 (cholecalciferol) (Drug); 2400 IU Vitamin D3 (cholecalciferol) (Drug); 6400 IU Vitamin D3 (cholecalciferol) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery |
28.5; 38.0; 55.6 | — |
| SECONDARY Maternal Health Status - Vitamin D Deficiency |
22.95; 11.36; 4.69 | — |
| SECONDARY Infant Health Status - Vitamin D Deficiency |
2.78; 8.11; 2.63 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00412074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.