At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Establishing the Vitamin D Requirements During Lactation
In Brief
A Phase 3 clinical trial evaluating 400 IU Vitamin D3 (cholecalciferol), 2400 IU Vitamin D3 (cholecalciferol), and 1 other intervention for Vitamin D Deficiency. Completed, enrolled 460 participants across 2 sites.
Detailed 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
Study Details
Timeline
Interventions
400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant