Vitamin D DeficiencyPhase 4NCT03141593
Oral Vitamin D Substitution Weekly or Monthly and Adherence
A Phase 4 study testing Vitamin D: liquid form, start weekly, Vitamin D: liquid form, start monthly and Vitamin D: solid form, start weekly in people with Vitamin D Deficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with supplementation by mouth. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D: liquid form, start weekly, Vitamin D: liquid form, start monthly and Vitamin D: solid form, start weekly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Oct 2017to 31 Oct 2018
- 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
- vitamin D deficiency by serum level <50 nmol/l
- polypharmacy defined as 4 daily medicines or more
- speaking German or Swiss German
Who cannot join
- hypercalcaemia
- substitution treatment with cholecalciferol in the past 3 months
- medication intake provided by a third person and not by the patient himself
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral Vitamin D Substitution Weekly or Monthly - Which Procedure Leads to Highest Adherence? A Prospective Intervention Study in Outpatient Care
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with supplementation by mouth. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Commercially available pharmaceutical forms are liquid in Switzerland (drops) and solid forms in Germany (tablets and capsules). Because therapeutic range of vitamin D3 is wide and toxicity is seldom reached, even after the consumption of 200'000 IU, and because the administration of 8 drops daily is inconvenient, weekly and monthly administrations of the cumulative amount (i.e., 5'600 IU weekly or 24'000 IU monthly) have been investigated. Both administration schedules are therapeutic equivalent. The study aims to investigate which form (liquid or solid) and which schedule (weekly or monthly) procure the highest adherence behavior with outpatients under polypharmacy i.e., with 4 or more medications daily. The investigators will use commercially available Swiss and German products.
Read the detailed description
Intervention study in patients with serum vitamin D <50 nmol/l and polypharmacy, defined as ≥4 medicaments/day. Treatment duration: 6 months. Treatment groups are defined as Lm (liquid monthly 24'000 IU); Lw (liquid weekly 5'600 IU); Sm (solid monthly 20'000 IU) and Sw (solid weekly 5'600 IU). Cross-over design with identical form (liquid or solid) and switching frequence, i.e. from weekly to monthly treatment and vice versa, for 3 months each.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D: liquid form, start weekly, Vitamin D: liquid form, start monthly, Vitamin D: solid form, start weekly, Vitamin D: solid form, start monthly
- Keywords
- adherence to medication, electronic monitoring
- 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 D: liquid form, start weeklyDrug
Also called Vitamin D3 Streuli
Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.
Vitamin D: liquid form, start monthlyDrug
Also called Vi-De 3 Monatsdosis
Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.
Vitamin D: solid form, start weeklyDrug
Also called Dekristolvit D3
Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.
Vitamin D: solid form, start monthlyDrug
Also called Dekristol
Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D: liquid form, start weekly | Active comparator | 5'600 IU weekly (1.4 ml oily drops) start for 3 months, will cross-over to 24'000 IU monthly (5 ml alcoholic drops) for the following 3 months. Receives: Drug: Vitamin D: liquid form, start weekly |
| Vitamin D: solid form, start weekly | Active comparator | 5'600 IU weekly (1 soft capsule) start for 3 months, will cross-over to 20'000 IU monthly (1 tablet) for the following 3 months. Receives: Drug: Vitamin D: solid form, start weekly |
| Vitamin D: liquid form, start monthly | Active comparator | 24'000 IU monthly (5 ml alcoholic drops) start for 3 months, will cross-over to 5'600 IU weekly (1.4 ml oily drops) for the following 3 months. Receives: Drug: Vitamin D: liquid form, start monthly |
| Vitamin D: solid form, start monthly | Active comparator | 20'000 IU monthly (1 tablet) start for 3 months, will cross-over to 5'600 IU weekly (1 soft capsule) for the following 3 months. Receives: Drug: Vitamin D: solid form, start monthly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to medication
Taking adherence: number of dosis taken divided by number of dosis prescribed. Timing adherence: number of dosis taken within a time interval (within 15% of the mean preset intake time) divided by number of dosis prescribed.
Measured: 3 months of treatment
Secondary outcomes (2)
Serum level of vitamin D
Level of serum vitamin D compared to baseline value.
Measured: 3 and 6 months
Patients preferences
Questionnaire with 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)
Measured: 3 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start9 Oct 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
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 University Hospital, Basel, SwitzerlandThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patient will be recruited by their general practitioners (GP) and allocated to the GP's form (liquid or solid). Patients will be randomly assigned to start weekly or monthly intake for 3 months, and switch to the other frequence for 3 more months.
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kurt E Hersberger, Prof, Study director, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141593
- Sponsor's protocol ID
- 2017-00300
- Other IDs
- 2017
- Status last verified
- Feb 2020
- First submitted
- 23 Mar 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Vitamin D Substitution Weekly or Monthly - Which Procedure Leads to Highest Adherence? A Prospective Intervention Study in Outpatient Care
- ClinicalTrials.gov ID
- NCT03141593
- Acronym / sponsor ID
- 2017-00300
- Conditions
- Vitamin D Deficiency
- Keywords
- adherence to medication, electronic monitoring
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 5 May 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.
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with supplementation by mouth. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Commercially available pharmaceutical forms are liquid in Switzerland (drops) and solid forms in Germany (tablets and capsules). Because therapeutic range of vitamin D3 is wide and toxicity is seldom reached, even after the consumption of 200'000 IU, and because the administration of 8 drops daily is inconvenient, weekly and monthly administrations of the cumulative amount (i.e., 5'600 IU weekly or 24'000 IU monthly) have been investigated. Both administration schedules are therapeutic equivalent. The study aims to investigate which form (liquid or solid) and which schedule (weekly or monthly) procure the highest adherence behavior with outpatients under polypharmacy i.e., with 4 or more medications daily. The investigators will use commercially available Swiss and German products.
Detailed description
Intervention study in patients with serum vitamin D <50 nmol/l and polypharmacy, defined as ≥4 medicaments/day. Treatment duration: 6 months. Treatment groups are defined as Lm (liquid monthly 24'000 IU); Lw (liquid weekly 5'600 IU); Sm (solid monthly 20'000 IU) and Sw (solid weekly 5'600 IU). Cross-over design with identical form (liquid or solid) and switching frequence, i.e. from weekly to monthly treatment and vice versa, for 3 months each.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patient will be recruited by their general practitioners (GP) and allocated to the GP's form (liquid or solid). Patients will be randomly assigned to start weekly or monthly intake for 3 months, and switch to the other frequence for 3 more months.
| Arm | Type | Receives |
|---|---|---|
| Vitamin D: liquid form, start weekly | Active comparator | Drug: Vitamin D: liquid form, start weekly5'600 IU weekly (1.4 ml oily drops) start for 3 months, will cross-over to 24'000 IU monthly (5 ml alcoholic drops) for the following 3 months. |
| Vitamin D: solid form, start weekly | Active comparator | Drug: Vitamin D: solid form, start weekly5'600 IU weekly (1 soft capsule) start for 3 months, will cross-over to 20'000 IU monthly (1 tablet) for the following 3 months. |
| Vitamin D: liquid form, start monthly | Active comparator | Drug: Vitamin D: liquid form, start monthly24'000 IU monthly (5 ml alcoholic drops) start for 3 months, will cross-over to 5'600 IU weekly (1.4 ml oily drops) for the following 3 months. |
| Vitamin D: solid form, start monthly | Active comparator | Drug: Vitamin D: solid form, start monthly20'000 IU monthly (1 tablet) start for 3 months, will cross-over to 5'600 IU weekly (1 soft capsule) for the following 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- vitamin D deficiency by serum level <50 nmol/l
- polypharmacy defined as 4 daily medicines or more
- speaking German or Swiss German
Key exclusion criteria (3 listed)
- hypercalcaemia
- substitution treatment with cholecalciferol in the past 3 months
- medication intake provided by a third person and not by the patient himself
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 D: liquid form, start weeklyAlso: Vitamin D3 StreuliPatient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months. | Drug | Vitamin D: liquid form, start weekly |
| Vitamin D: liquid form, start monthlyAlso: Vi-De 3 MonatsdosisPatient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months. | Drug | Vitamin D: liquid form, start monthly |
| Vitamin D: solid form, start weeklyAlso: Dekristolvit D3Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months. | Drug | Vitamin D: solid form, start weekly |
| Vitamin D: solid form, start monthlyAlso: DekristolPatient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months. | Drug | Vitamin D: solid form, start monthly |
Primary outcome
Adherence to medication
Time frame: 3 months of treatment
Taking adherence: number of dosis taken divided by number of dosis prescribed. Timing adherence: number of dosis taken within a time interval (within 15% of the mean preset intake time) divided by number of dosis prescribed.
2 secondary outcomes
Serum level of vitamin D
Time frame: 3 and 6 months
Patients preferences
Time frame: 3 months of treatment
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 12 Feb 2020.
- Individual participant dataSharing planned: No. not decided yet
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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.
Kurt E Hersberger, Prof study director
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D: liquid form, start weekly, Vitamin D: liquid form, start monthly and Vitamin D: solid form, start weekly in people with Vitamin D Deficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 3 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 12 Feb 2020. 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 Switzerland. 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.
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?
Adherence to medication (time frame: 3 months of treatment). 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 12 Feb 2020.