Vitamin D DeficiencyPhase 3DO-ITNCT03920150
Vitamin D 24'000 IU for Oral Intermittent Supplementation
A Phase 3 study testing Vitamin D3 and Vitamin D oily capsules 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 oral supplementation. 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 D3 and Vitamin D oily capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Sep 2019to 31 May 2020
- Phase
- Phase 3
- 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
Who cannot join
- hypercalcaemia
Trial locations and contacts
1 site in 1 country.
About this study
Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values >75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.
Read the detailed description
Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).
Group IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).
Group IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.
All 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3, Vitamin D oily capsules
- Keywords
- optimal vitamin D value
- 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 D3Drug
Also called Vi-De 3 Monatsdosis
Patient will be treated with 3 doses of alcoholic solution for 3 months.
Vitamin D oily capsulesDrug
Patient will be treated with 3 capsules for 3 months.
Vitamin D oily capsulesDrug
Patient will be treated with weekly capsules for an individually calculated number of weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months Receives: Drug: Vitamin D3 |
| IMP | Active comparator | Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months Receives: Drug: Vitamin D oily capsules |
| IMP + loading dose | Active comparator | Vitamin D oily capsules containing 24'000 IU vitamin D for an individual number of weeks calculated with the formula: 40 x (100 - actual value [nmol/l] x body weight [kg] / 24'000 IU. Receives: Drug: Vitamin D oily capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum level of vitamin D
Level of serum vitamin D after 3 month treatment compared to baseline value
Measured: 3 months of treatment
Secondary outcomes (3)
Serum level of vitamin D after loading dose
Level of serum vitamin D > 75 nmol/l after an individual number of treatment weeks, calculated with a loading dose formula.
Measured: up to 4 months of treatment
Adverse Drug Reactions
Number and severity of adverse drug reactions during treatment
Measured: 3 months of treatment
Adherence to medication
Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.
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 posted18 Apr 2019
- Study start30 Sep 2019
- Primary completion31 May 2020
- Study completion31 May 2020
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be recruited by their general practitioner. Patients will be randomly assigned to be supplemented with monthly solution (control group), monthly capsules (IMP group) or weekly capsules after calculation of a individual loading dose (IMP + loading dose group).
- Masking
- None (open label)
- Enrolment
- 58 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 chair, Pharmaceutical Care Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920150
- Sponsor's protocol ID
- 2019-00987
- Other IDs
- 2019
- Acronym
- DO-IT
- Status last verified
- Jun 2020
- First submitted
- 12 Apr 2019
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D 24'000 IU for Oral Intermittent Supplementation
- ClinicalTrials.gov ID
- NCT03920150
- Acronym / sponsor ID
- DO-IT / 2019-00987
- Conditions
- Vitamin D Deficiency
- Keywords
- optimal vitamin D value
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 18 Apr 2019 (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 oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values >75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.
Detailed description
Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).
Group IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).
Group IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.
All 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patient will be recruited by their general practitioner. Patients will be randomly assigned to be supplemented with monthly solution (control group), monthly capsules (IMP group) or weekly capsules after calculation of a individual loading dose (IMP + loading dose group).
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Vitamin D35 ml alcoholic solution containing 24'000 IU vitamin D for 3 months |
| IMP | Active comparator | Drug: Vitamin D oily capsulesVitamin D oily capsules containing 24'000 IU vitamin D for 3 months |
| IMP + loading dose | Active comparator | Drug: Vitamin D oily capsulesVitamin D oily capsules containing 24'000 IU vitamin D for an individual number of weeks calculated with the formula: 40 x (100 - actual value [nmol/l] x body weight [kg] / 24'000 IU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- vitamin D deficiency by serum level <50 nmol/l
Key exclusion criteria (1 listed)
- hypercalcaemia
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 D3Also: Vi-De 3 MonatsdosisPatient will be treated with 3 doses of alcoholic solution for 3 months. | Drug | Control |
| Vitamin D oily capsulesPatient will be treated with 3 capsules for 3 months. | Drug | IMP |
| Vitamin D oily capsulesPatient will be treated with weekly capsules for an individually calculated number of weeks. | Drug | IMP + loading dose |
Primary outcome
Serum level of vitamin D
Time frame: 3 months of treatment
Level of serum vitamin D after 3 month treatment compared to baseline value
3 secondary outcomes
Serum level of vitamin D after loading dose
Time frame: up to 4 months of treatment
Adverse Drug Reactions
Time frame: 3 months of treatment
Adherence to medication
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 4 Jun 2020.
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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 chair
Pharmaceutical Care Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 and Vitamin D oily capsules 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 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 4 Jun 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Serum level of vitamin D (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 4 Jun 2020.