Vitamin D 24'000 IU for Oral Intermittent Supplementation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vitamin D 24'000 IU for Oral Intermittent Supplementation

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Vitamin D oily capsules
* Drug: Vitamin D oily capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: vitamin D deficiency by serum level <50 nmol/l Exclusion Criteria: hypercalcaemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months | Drug: Vitamin D3<br>* Patient will be treated with 3 doses of alcoholic solution for 3 months.<br>* Other names: Vi-De 3 Monatsdosis;|
| Active Comparator: IMP<br>Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months | Drug: Vitamin D oily capsules<br>* Patient will be treated with 3 capsules for 3 months.<br>|
| Active Comparator: IMP + loading dose<br>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. | Drug: Vitamin D oily capsules<br>* Patient will be treated with weekly capsules for an individually calculated number of weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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optimal vitamin D value