Vitamin D 24'000 IU for Oral Intermittent Supplementation (DO-IT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03920150|
Recruitment Status : Completed
First Posted : April 18, 2019
Last Update Posted : June 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Vitamin D3 Drug: Vitamin D oily capsules||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Parallel Assignment|
|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).|
|Masking:||None (Open Label)|
|Official Title:||Vitamin D 24'000 IU for Oral Intermittent Supplementation|
|Actual Study Start Date :||September 30, 2019|
|Actual Primary Completion Date :||May 31, 2020|
|Actual Study Completion Date :||May 31, 2020|
Active Comparator: Control
5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months
Drug: Vitamin D3
Patient will be treated with 3 doses of alcoholic solution for 3 months.
Other Name: Vi-De 3 Monatsdosis
Active Comparator: IMP
Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months
Drug: Vitamin D oily capsules
Patient will be treated with 3 capsules for 3 months.
Active Comparator: IMP + loading dose
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
Patient will be treated with weekly capsules for an individually calculated number of weeks.
- Serum level of vitamin D [ Time Frame: 3 months of treatment ]Level of serum vitamin D after 3 month treatment compared to baseline value
- Serum level of vitamin D after loading dose [ Time Frame: 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 [ Time Frame: 3 months of treatment ]Number and severity of adverse drug reactions during treatment
- Adherence to medication [ Time Frame: 3 months of treatment ]Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920150
|Pharmaceutical Care Research Group|
|Basel, Switzerland, 4056|
|Study Chair:||Kurt E Hersberger, Prof||Pharmaceutical Care Research Group|