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NCT00697294 · ClinicalTrials.gov registry record · NA
Impact of Vitamin D Status on Bones in Breastfed Infants
A NA study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT00697294 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 80 participants.
The verdict
NCT00697294, a NA study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Tri-Vi-Sol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-07 |
| Est. Completion | 2011-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00697294
The ClinicalTrials.gov registry entry for NCT00697294 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tri-Vi-Sol is the first listed.
NCT00697294 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00697294 about?
NCT00697294 is a clinical study titled "Impact of Vitamin D Status on Bones in Breastfed Infants". 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 ...
What is the current status of trial NCT00697294?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2008-07. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00697294?
The interventions under investigation include: Tri-Vi-Sol (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00697294?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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