Deficiency, Vitamin DPhase 4NCT02186106
Dosage Calculation for Vitamin D Treatment
A Phase 4 study testing Cholecalciferol in people with Deficiency, Vitamin D and Obesity, run by Bispebjerg Hospital.
Trial summary
Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis. We've conducted two studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Deficiency, Vitamin D, Obesity
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Sep 2013
- Phase
- Phase 4
- 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
- severe hypovitaminosis D (25OH-vit.D <25 nmol/L)
Who cannot join
- Malabsorption
- Renal disease
- Other treatment with vitamin D related products
- Patients with a recent travel history with suspected increased sun exposure
About this study
Official title: The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D
Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis.
We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.
- Conditions
- Deficiency, Vitamin D, Obesity
- Being tested
- Cholecalciferol
- Medical subject headings
- Vitamin D Deficiency, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Dekristol capsules of 20.000 IU pr. capsule
| Study group | Role | What they receive |
|---|---|---|
| Loading dose substitution | Experimental | Substituted with a highdose of cholecalciferol at study start Receives: Drug: Cholecalciferol |
| Historic controls | No intervention | Control subjects from journal archive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline value of [25-OH-vitamin-D]
Measured: 1 week, 3 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deficiency, Vitamin DStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasmus Bo Jansen, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186106
- Sponsor's protocol ID
- H-4-2011-094
- Status last verified
- Jul 2014
- First submitted
- 3 Jul 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Loading Doses of Cholecalciferol on the Serum Concentration of 25-OH-vitamin-D
- ClinicalTrials.gov ID
- NCT02186106
- Acronym / sponsor ID
- H-4-2011-094
- Conditions
- Deficiency, Vitamin D, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Jul 2014 (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.
Severe vitamin D deficiency can be treated with oral loading doses of cholecalciferol. Our objective was to determine how to calculate the quantity of cholecalciferol needed for supplementation by single algorithm, usable on a patient-to-patient basis.
We've conducted two studies. Study 1 was done retroactively and included 88 patients treated for low vitamin D, 60 of those with a loading dose. The second study included 29 patients and aimed to test the validity of an algorithm based on data from study 1, which included patient BMI. Both studies used oral loading doses and daily supplementation of cholecalciferol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loading dose substitution | Experimental | Drug: CholecalciferolSubstituted with a highdose of cholecalciferol at study start |
| Historic controls | No intervention | –Control subjects from journal archive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe hypovitaminosis D (25OH-vit.D <25 nmol/L)
Key exclusion criteria (4 listed)
- Malabsorption
- Renal disease
- Other treatment with vitamin D related products
- Patients with a recent travel history with suspected increased sun exposure
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: Dekristol capsules of 20.000 IU pr. capsule | Drug | Loading dose substitution |
Primary outcome
Change in baseline value of [25-OH-vitamin-D]
Time frame: 1 week, 3 weeks and 3 months
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 10 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cholecalciferol in people with Deficiency, Vitamin D and Obesity, run by Bispebjerg Hospital.
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 4 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 10 Jul 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in baseline value of [25-OH-vitamin-D] (time frame: 1 week, 3 weeks and 3 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 10 Jul 2014.