Vitamin D DeficiencyVitDNCT03099759
Vitamin D Raising and Maintaining Blood Serum 25(OH)D3 Levels
A study testing Vitamin D in people with Vitamin D Deficiency, run by The Cleveland Clinic.
Trial summary
Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 27 Jun 2016to 31 May 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low Vitamin D level
Who cannot join
- Normal Vitamin D level, already taking Vitamin D, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.
About this study
Official title: Effectiveness of Various Vitamin D Protocols on Raising and Maintaining Blood Serum 25(OH)D3 Levels Over a Three Month Period
Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time.
Read the detailed description
Vitamin D has shown multiple health benefits specifically in regards to bone healing. To the investigators knowledge there are currently no protocols for Vitamin D supplementation in the Orthopedic community for patients recovering from fractures. The investigators study will monitor 3 different groups of volunteers taking various Vitamin D regimens and how participants blood serum 25(OH)D3 levels are effected throughout a 3 month period. The 3 groups will include: 1) 100,000 units D2 once on day one, 2) 100,000 units D2 taken once a week x 12 weeks, 3) 50,000 units D2 x 10 days, then 2000 units D3 taken daily for the remainder of the study period. There will be 15-20 volunteers randomly assigned to each of the 3 groups. The investigators will have each volunteer from the 3 groups have blood drawn a total of 4 times throughout the course of this study: prior to the study, week 2, week 6, and week 12. From these results the investigators will determine which protocol most effectively raises and maintains vitamin D levels in the volunteers through this 3 month period. The investigators will also use this data to determine which protocol is not only most cost efficient but also easiest to follow by individuals. The investigators are hoping that this study may help finally develop a universal orthopedic protocol for vitamin D supplementation in patients recovering from fractures.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D
- Keywords
- Vitamin D Dosing Regimens, Blood Serum 25(OH)D3 Levels
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Ergocalciferol, cholecalciferol
Vitamin D2/D3
| Study group | Role | What they receive |
|---|---|---|
| Vitamin Dose Group 100,000 Units | Active comparator | 100,000 units Vitamin D2 one time only. Receives: Dietary Supplement: Vitamin D |
| Vitamin Dose Group 100,000 Units D2 | Active comparator | 100,000 units vitamin D2 weekly for three months. Receives: Dietary Supplement: Vitamin D |
| Vitamin Dose Group 50,000/2,000 D2/D3 | Active comparator | 50,000 units Vitamin D2 for 10 days followed by 2,000 units Vitamin D3 daily the remainder of the three month study period. Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D
Effectiveness of various Vitamin D protocols on raising and maintaining blood serum 25(OH)D3 levels over a three month period from baseline to 3 months with participants blood draws at initial, week 2, week 6 and week 12 time frame.
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start27 Jun 2016
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Brentwood Foundation
- Responsible party
- Sponsor
- Investigators
- Damien Billow, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099759
- Sponsor's protocol ID
- IRB 16-028
- Acronym
- VitD
- Status last verified
- Jun 2017
- First submitted
- 23 Mar 2017
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Various Vitamin D Protocols on Raising and Maintaining Blood Serum 25(OH)D3 Levels Over a Three Month Period
- ClinicalTrials.gov ID
- NCT03099759
- Acronym / sponsor ID
- VitD / IRB 16-028
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Dosing Regimens, Blood Serum 25(OH)D3 Levels
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Brentwood Foundation
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Analyze the amount of change in blood serum Vitamin D levels in patients of 3 different dosing groups and how their levels change over a 3 month period of time.
Detailed description
Vitamin D has shown multiple health benefits specifically in regards to bone healing. To the investigators knowledge there are currently no protocols for Vitamin D supplementation in the Orthopedic community for patients recovering from fractures. The investigators study will monitor 3 different groups of volunteers taking various Vitamin D regimens and how participants blood serum 25(OH)D3 levels are effected throughout a 3 month period. The 3 groups will include: 1) 100,000 units D2 once on day one, 2) 100,000 units D2 taken once a week x 12 weeks, 3) 50,000 units D2 x 10 days, then 2000 units D3 taken daily for the remainder of the study period. There will be 15-20 volunteers randomly assigned to each of the 3 groups. The investigators will have each volunteer from the 3 groups have blood drawn a total of 4 times throughout the course of this study: prior to the study, week 2, week 6, and week 12. From these results the investigators will determine which protocol most effectively raises and maintains vitamin D levels in the volunteers through this 3 month period. The investigators will also use this data to determine which protocol is not only most cost efficient but also easiest to follow by individuals. The investigators are hoping that this study may help finally develop a universal orthopedic protocol for vitamin D supplementation in patients recovering from fractures.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vitamin Dose Group 100,000 Units | Active comparator | Dietary Supplement: Vitamin D100,000 units Vitamin D2 one time only. |
| Vitamin Dose Group 100,000 Units D2 | Active comparator | Dietary Supplement: Vitamin D100,000 units vitamin D2 weekly for three months. |
| Vitamin Dose Group 50,000/2,000 D2/D3 | Active comparator | Dietary Supplement: Vitamin D50,000 units Vitamin D2 for 10 days followed by 2,000 units Vitamin D3 daily the remainder of the three month study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low Vitamin D level
Key exclusion criteria (1 listed)
- Normal Vitamin D level, already taking Vitamin D, any form of steroids, weight-loss drugs, anti-tuberculosis drugs, high blood pressure drugs, high cholesterol drugs, endocrine disease, being treated for any form of cancer.
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 |
|---|---|---|
| Vitamin DAlso: Ergocalciferol, cholecalciferolVitamin D2/D3 | Dietary supplement | Vitamin Dose Group 100,000 Units, Vitamin Dose Group 100,000 Units D2, Vitamin Dose Group 50,000/2,000 D2/D3 |
Primary outcome
Vitamin D
Time frame: Three Months
Effectiveness of various Vitamin D protocols on raising and maintaining blood serum 25(OH)D3 levels over a three month period from baseline to 3 months with participants blood draws at initial, week 2, week 6 and week 12 time frame.
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 21 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Damien Billow, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Vitamin D Deficiency, run by The Cleveland Clinic.
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 1 inclusion and 1 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Vitamin D (time frame: Three Months). 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 21 Jun 2017.