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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | 5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months |
|
| IMP | Active Comparator | Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | Patient will be treated with 3 doses of alcoholic solution for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of vitamin D | Level of serum vitamin D after 3 month treatment compared to baseline value | 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 4 months of treatment |
| Adverse Drug Reactions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt E Hersberger, Prof | Pharmaceutical Care Research Group | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Care Research Group | Basel | 4056 | Switzerland |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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).
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| Vitamin D oily capsules | Drug | Patient will be treated with 3 capsules for 3 months. |
|
| Vitamin D oily capsules | Drug | Patient will be treated with weekly capsules for an individually calculated number of weeks. |
|
Number and severity of adverse drug reactions during treatment
| 3 months of treatment |
| Adherence to medication | Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100. | 3 months of treatment |
| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |