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NCT00732758 · ClinicalTrials.gov registry record · Phase 1
Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 157
- Enrollment target
NCT00732758 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 157 participants.
The verdict
NCT00732758, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 157 participants
- Enrollment target
Study Summary
The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian children. We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000 IU/day vs. placebo) initiated during October through March (during fall and winter) in 8 to 14 year old African American and Caucasian children. The results of the trial will help establish the cutoff threshold value of serum 25(OH)D for defining vitamin D insufficiency in preadolescent and adolescent children. Safety of vitamin D supplementation will be assessed by measuring serum calcium at 0, 2 and 6 months and by monitoring for adverse events. Currently recommended adequate intake for vitamin D of 200 IU daily may not meet the body's daily needs for vitamin D. Therefore, it is likely that a higher level of daily vitamin D intake may be needed to meet the body's skeletal and non-skeletal demands for vitamin D. Determining the dietary required intake of vitamin D for the prevention of vitamin D insufficiency during childhood has immense public health potential for addressing health disparities and ensuring better bone health during adulthood. The primary outcome measure will be serum 25(OH)D and parathyroid hormone (PTH). The secondary outcome measures will include: markers of bone formation (serum P1NP) and bone resorption (serum CTX).We will also examine differences in serum 25(OH)D, PTH, and markers of bone turnover in African American vs. Caucasian children.
Interventions
- DIETARY_SUPPLEMENT Vitamin D3 1000 IU
- DIETARY_SUPPLEMENT Placebo Tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00732758
The ClinicalTrials.gov registry entry for NCT00732758 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vitamin D3 1000 IU is the first listed.
NCT00732758 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00732758 about?
NCT00732758 is a clinical study titled "Defining Vitamin D Insufficiency in School Age Children: A Randomized Placebo Controlled Trial of Vitamin D3". The study objective is to characterize the threshold levels of serum 25-hydroxyvitamin D for the definition of vitamin D insufficiency in 8-14 year old African American and Caucasian children. We propose a 6 month randomized placebo controlled trial of vitamin D (vitamin D3 1000 IU/day vs. placebo)...
What is the current status of trial NCT00732758?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 157 participants. The study started on 2008-10. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00732758?
The interventions under investigation include: Vitamin D3 1000 IU (DIETARY_SUPPLEMENT), Placebo Tablet (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00732758?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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