Vitamin D Deficiency Clinical Trial
Official title:
Establishing the Vitamin D Requirements During Lactation
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
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. On 2/5/2009,
the protocol was amended and the Group B arm was dropped; infants of active subjects
randomized to Group B as of 2/5/2009 were put on open label treatment (400 IU D3/d) through
study completion. Newly enrolled subjects after this date were randomized to Group A or Group
C only.
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.
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