At a glance
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Vitamin D Status and Impact on Bone Mineralization in Human Milk Fed Hispanic and Caucasian Infants
In Brief
A clinical study evaluating Tri-Vi-Sol for Vitamin D Deficiency. Completed, enrolled 80 participants across 3 sites.
Detailed Summary
Vitamin D deficiency is widespread and linked to decreased bone mineral content. Little data exists regarding the vitamin D status and the relationship of 25-hydroxyvitamin D (25-OHD) status to functional bone health outcomes in Hispanic infants. To evaluate this, we plan an observational cohort of full term, healthy, exclusively breastfed Hispanic and Caucasian infants. We hypothesize serum 25-OHD measured in cord blood will be significantly lower in Hispanic than Caucasian infants, with 25-OHD less than 20 ng/mL found in at least 50% of Hispanic neonates. Secondary aims evaluate the relationship between 25-OHD levels and bone mineral status at baseline and after 3 months of 400 IU/day supplemental vitamin D3. Whole body bone density scan (DXA) and bone ultrasound (SOS U/S) will be measured shortly after birth, then again after supplementation. Data from this study will provide information needed to design further randomized trials and interventions.
Study Details
Timeline
Interventions
All subjects will begin vitamin D supplementation at the first outpatient visit (at 1 week of life) and will continue through the second outpatient visit (at 3 months of age). Dosage will be 400 IU/day of vitamin D in the form of Tri-Vi-Sol vitamin drops.