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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
460
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
University of Rochester Medical Center
Rochester, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery
Time frame: to 7 months postpartum
Maternal Health Status - Vitamin D Deficiency
Percentage of subjects with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7
Time frame: to 7 months postpartum
Infant Health Status - Vitamin D Deficiency
Percentage of infants with 25-hydroxyvitamin D \[25(OH)D\] concentration \<20 ng/mL at Visit 7
Time frame: to 7 months of age
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