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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D: liquid form, start weekly | Drug | Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of vitamin D | Level of serum vitamin D compared to baseline value. | 3 and 6 months |
| Patients preferences | Questionnaire with 5-point Likert scale (from 1=strongly disagree to 5=strongly agree) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt E Hersberger, Prof | University of Basel | Study Director |
| 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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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.
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| Vitamin D: liquid form, start monthly | Drug | Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months. |
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| Vitamin D: solid form, start weekly | Drug | Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months. |
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| Vitamin D: solid form, start monthly | Drug | Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months. |
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| 3 months of treatment |
| D009750 |
| Nutritional and Metabolic Diseases |