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

July 25, 2012 updated by: University of South Florida

A Randomized 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Dietary supplement: Cholecalciferol
Cholecalciferol 50,000 IU PO every 10 days for 40 days
Other Names:
  • Vitamin D3
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.
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 Names:
  • Vitamin D3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
40 days +/- 3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events throughout the 40 day study
Time Frame: 40 +/- 3 days
40 +/- 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VitD3USFstudy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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