A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients
Completed · Not applicable
Conditions studied: Vitamin D 25 OH Deficiency
In brief
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.
Key facts
- Study ID
- NCT01650883
- Run by
- University of South Florida
- People needed
- 56
- Starts
- 2009-03-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2012-07-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 - open ended to both males and females
- Able to give informed consent
- 25 OH-Vitamin D level of < or = 32 mg/dL
- Creatinine of < 1.9 or Creatinine Clearance (CrCl) of greater than or equal to 40 mL/min/1.73 m\^2.
- English speaking
You may not qualify if…
- Creatinine of greater to or equal to 1.9 or CrCl less than 40 mL/min/1.73 m\^2 (as calculated on MDRD.com)
- History of hyperparathyroidism, a known risk factor for hyperkalemia
- History of nephrolithiasis given that hypervitaminosis D can increase the risk of nephrolithiasis
- Current use of any dose of glucocorticoids, a known risk factor for hypercalcuria
- History of sarcoidosis, tuberculosis, or Paget's disease which are known risk factors for hypercalcemia
- (Random) Molar Calcium:Creatinine urinary concentration of > 1
Where it is running
- University of South Florida — Tampa, Florida, United States
Full record on ClinicalTrials.gov
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