Vitamin D 25 OH DeficiencyNCT01650883
A Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients
A study testing Cholecalciferol and Cholecalciferol 5,000 IU in people with Vitamin D 25 OH Deficiency, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D 25 OH Deficiency
- What is being tested?
- Cholecalciferol and Cholecalciferol 5,000 IU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D 25 OH Deficiency
- Being tested
- Cholecalciferol, Cholecalciferol 5,000 IU
- Keywords
- Vitamin D3, Vitamin D 25 OH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called Vitamin D3
Cholecalciferol 50,000 IU PO every 10 days for 40 days
Cholecalciferol 5,000 IUDietary supplement
Also called Vitamin D3
Cholecalciferol 5,000 IU PO daily for 40 days + 1200 mg Calcium Carbonate PO daily for 40 days.
| Study group | Role | What they receive |
|---|---|---|
| Cholecaliferol 50,000 IU PO Q10 days x 40 days | Experimental | 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. Receives: Dietary Supplement: Cholecalciferol |
| Cholecalciferol 5,000 IU PO daily x 40 days | Experimental | 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. Receives: Dietary Supplement: Cholecalciferol 5,000 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 40 days +/- 3 days
Secondary outcomes (1)
Adverse events throughout the 40 day study
Measured: 40 +/- 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2012 (estimated)
- Study startMar 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D 25 OH DeficiencyStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julio Gonzalez, MD, Principal investigator, University of South Florida College of MedicineJohn D Carter, MD, Principal investigator, University of South Florida Division of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01650883
- Sponsor's protocol ID
- VitD3USFstudy
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Open-label Comparison of Two Vitamin D3 Repletion Strategies in Vitamin D Deficient Patients
- ClinicalTrials.gov ID
- NCT01650883
- Acronym / sponsor ID
- VitD3USFstudy
- Conditions
- Vitamin D 25 OH Deficiency
- Keywords
- Vitamin D3, Vitamin D 25 OH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 26 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecaliferol 50,000 IU PO Q10 days x 40 days | Experimental | Dietary Supplement: CholecalciferolPatients 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. |
| Cholecalciferol 5,000 IU PO daily x 40 days | Experimental | Dietary Supplement: Cholecalciferol 5,000 IUPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecalciferolAlso: Vitamin D3Cholecalciferol 50,000 IU PO every 10 days for 40 days | Dietary supplement | Cholecaliferol 50,000 IU PO Q10 days x 40 days |
| Cholecalciferol 5,000 IUAlso: Vitamin D3Cholecalciferol 5,000 IU PO daily for 40 days + 1200 mg Calcium Carbonate PO daily for 40 days. | Dietary supplement | Cholecalciferol 5,000 IU PO daily x 40 days |
Primary outcome
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
1 secondary outcome
Adverse events throughout the 40 day study
Time frame: 40 +/- 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2012.
Related trials for Vitamin D 25 OH Deficiency
Enrolling by invitationObservational study
ALPCO 25(OH) Vitamin D CLIA Kit - Fresh Versus Frozen Serum and Plasma Stability Study
Vitamin D Deficiency, Vitamin D Insufficiency
RecruitingObservational study
Vitamin D and Health Status of British African-Caribbean Women
Vitamin D Deficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julio Gonzalez, MD principal investigator
University of South Florida College of Medicine
John D Carter, MD principal investigator
University of South Florida Division of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol and Cholecalciferol 5,000 IU in people with Vitamin D 25 OH Deficiency, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2012.