Vitamin D Deficiency
Conditions
Keywords
optimal vitamin D value
Brief 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). 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.
Interventions
DRUGVitamin D3
Patient will be treated with 3 doses of alcoholic solution for 3 months.
DRUGVitamin D oily capsules
Patient will be treated with 3 capsules for 3 months.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* vitamin D deficiency by serum level \<50 nmol/l
Exclusion criteria
* hypercalcaemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum level of vitamin D | 3 months of treatment | Level of serum vitamin D after 3 month treatment compared to baseline value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum level of vitamin D after loading dose | up to 4 months of treatment | Level of serum vitamin D \> 75 nmol/l after an individual number of treatment weeks, calculated with a loading dose formula. |
| Adverse Drug Reactions | 3 months of treatment | Number and severity of adverse drug reactions during treatment |
| Adherence to medication | 3 months of treatment | Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100. |
Countries
Switzerland
Outcome results
None listed