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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D3 Drug: Vitamin D oily capsules Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Serum level of vitamin D [ Time Frame: 3 months of treatment ]
    Level of serum vitamin D after 3 month treatment compared to baseline value


Secondary Outcome Measures :
  1. 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.

  2. Adverse Drug Reactions [ Time Frame: 3 months of treatment ]
    Number and severity of adverse drug reactions during treatment

  3. Adherence to medication [ Time Frame: 3 months of treatment ]
    Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • vitamin D deficiency by serum level <50 nmol/l

Exclusion Criteria:

  • hypercalcaemia

Information from the National Library of Medicine

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


Locations
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Switzerland
Pharmaceutical Care Research Group
Basel, Switzerland, 4056
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Kurt E Hersberger, Prof Pharmaceutical Care Research Group
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03920150    
Other Study ID Numbers: 2019-00987
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
optimal vitamin D value
Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents