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NCT01650883 · ClinicalTrials.gov registry record · NA
A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients
A NA study, sponsored by University of South Florida.
- Completed
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT01650883 is a NA study that has completed, run by University of South Florida. The registered enrollment target is 56 participants.
The verdict
NCT01650883, a NA study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether one of two Vitamin D3 (cholecalciferol) oral treatment regimens is superior to the other in normalizing Vitamin 25 OHD serum levels. While these two regimens in the end provide equal total dosing, the two arms differ in frequency and dosing during a 40 day treatment plan. The primary endpoint will be a direct comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a paired T-test. Secondary endpoints include record of adverse events throughout the 40 day study period as well as changes in basic laboratory values including CMP and ionized Calcium. The investigators hypothesize that the Cholecalciferol (Vitamin D3) daily dosing arm of 5000 IU daily will result in more efficient replacement as compared to the 50,000 IU dosing given every 10 days. Our goal will be to achieve a serum Vitamin 25 OH D level of \> 50 mg/dL at day 40. The investigators propose that 75% of the subjects on daily Vitamin D3 will achieve this level and that 35% of the subjects in the every 10 days dosing arm will reach this goal.
Interventions
- DIETARY_SUPPLEMENT Cholecalciferol
- DIETARY_SUPPLEMENT Cholecalciferol 5,000 IU
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01650883
The ClinicalTrials.gov registry entry for NCT01650883 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cholecalciferol is the first listed.
NCT01650883 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01650883 about?
NCT01650883 is a clinical study titled "A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients". The purpose of this study is to determine whether one of two Vitamin D3 (cholecalciferol) oral treatment regimens is superior to the other in normalizing Vitamin 25 OHD serum levels. While these two regimens in the end provide equal total dosing, the two arms differ in frequency and dosing during a ...
What is the current status of trial NCT01650883?
This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2009-03. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01650883?
The interventions under investigation include: Cholecalciferol (DIETARY_SUPPLEMENT), Cholecalciferol 5,000 IU (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01650883?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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