Impact of Vitamin D Status on Bones in Breastfed Infants
Completed · Not applicable
Conditions studied: Vitamin D Deficiency
In brief
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.
Key facts
- Study ID
- NCT00697294
- Run by
- Baylor College of Medicine
- People needed
- 80
- Starts
- 2008-07-01
- Expected to finish
- 2011-11-01
- Last updated by the study team
- 2011-12-05
Who can join
Age: any. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Full term infants (37-42 weeks)
- Appropriate for gestational age
- Free of major congenital anomalies
- Born to mothers without a history of diabetes or chronic illness who intend to exclusively breastfeed
You may not qualify if…
- Any child who does not meet the above inclusion criteria
- Insufficient cord blood available to determine cord 25-hydroxyvitamin D status
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
- Ben Taub General Hospital — Houston, Texas, United States
- St Lukes Episcopal Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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