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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: Completed NA study, sponsored by Baylor College of Medicine.
NCT00697294 is a NA study that has completed, run by Baylor College of Medicine. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00697294 record still lists
NCT00697294 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Tri-Vi-Sol is the first listed.
NCT00697294 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00697294's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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