A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients

• ClinicalTrials.gov Identifier: NCT01650883
• Recruitment Status: Completed
• First Posted: July 26, 2012
• Last Update Posted: July 26, 2012
• Sponsor: University of South Florida
• Information provided by (Responsible Party): University of South Florida

Tracking Information

• First Submitted Date: July 23, 2012
• First Posted Date: July 26, 2012
• Last Update Posted Date: July 26, 2012
• Study Start Date: March 2009
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 25, 2012): The primary endpoint will be a direct comparison of two dosing regimens of Vitamin D3 repletion at day 40 (+/- 3 days) using a paired sample T-test by measuring the change in Vitamin D 25 OH from baseline to day 40 of treatment for both treatment groups. [ Time Frame: 40 days +/- 3 days ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: July 25, 2012): Adverse events throughout the 40 day study [ Time Frame: 40 +/- 3 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients
• Official Title: A Randomized Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients

Brief 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.

Detailed Description

This is a 40 day randomized prospective open-label study of two arms of vitamin D repletion protocols. USF clinic patients seen in the Rheumatology clinic, who meet criteria and have a baseline vitamin 25 OH D level of less than or equal to 32 mg/dL, will be randomized to two treatment arms. A Vitamin 25 OH D level of less than 32 mg/dL but above 20 mg/dL will be defined as insufficient. Similarly, a vitamin 25 OH D level of less than or equal to 20 mg/dL will be defined as deficient.

Patients in arm one will be repleted with Cholecalciferol (Vitamin D3) at 5000 IU orally daily for 40 days. Arm two of this treatment protocol will consist of 50,000 IU cholecalciferol (Vitamin D3) orally every 10 days starting on day 1 for 40 days. All subjects in both groups will receive a total dose of 200,000 IU of Vitamin D3 after 40 days of treatment. Each patient will also receive oral supplementation of 1200 mg daily calcium carbonate. Patients will return to clinic on day 40 (+/- 3 days) for a follow up serum vitamin 25 OH D and Calcium level. Compliance will be checked at that time with a pill count.

Clinical Significance: This trial asks the question as to whether one oral repletion therapy is superior to another in a 40 day time period. Given that current standard of care is based on individual practitioner experience, it may be beneficial for a standard protocol.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Vitamin D 25 OH Deficiency

Intervention

• Dietary Supplement: Cholecalciferol
  Cholecalciferol 50,000 IU PO every 10 days for 40 days
  Other Name: Vitamin D3
• Dietary Supplement: Cholecalciferol 5,000 IU
  Cholecalciferol 5,000 IU PO daily for 40 days + 1200 mg Calcium Carbonate PO daily for 40 days.
  Other Name: Vitamin D3

Study Arms

• Experimental: Cholecaliferol 50,000 IU PO Q10 days x 40 days
  Patients in this arm receive Cholecalciferol (vitamin D3) via PO route every 10 days for 40 days for a total of 200,000 IU of Vitamin D3. They also receive daily 1200 mg of Calcium Carbonate via PO route daily for 40 days.
  Intervention: Dietary Supplement: Cholecalciferol
• Experimental: Cholecalciferol 5,000 IU PO daily x 40 days
  Patients in this arm receive 5,000 IU of Cholecalciferol (Vitamin D3) via PO route daily for 40 days for a total of 200,000 IU. These patients also receive 1200 mg of daily Calcium Carbonate via PO route for 40 days.
  Intervention: Dietary Supplement: Cholecalciferol 5,000 IU

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 25, 2012): 56
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01650883
• Other Study ID Numbers: VitD3USFstudy
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of South Florida
• Study Sponsor: University of South Florida
• Collaborators: Not Provided

Investigators

• Principal Investigator: Julio Gonzalez, MD; University of South Florida College of Medicine
• Principal Investigator: John D Carter, MD; University of South Florida Division of Rheumatology

• PRS Account: University of South Florida
• Verification Date: July 2012