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Vitamin D 24'000 IU for Oral Intermittent Supplementation (DO-IT)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Vitamin D3
Vitamin D oily capsules
Vitamin D oily capsules
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring optimal vitamin D value

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • hypercalcaemia

Sites / Locations

  • Pharmaceutical Care Research Group

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Control

IMP

IMP + loading dose

Arm Description

5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months

Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months

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.

Outcomes

Primary Outcome Measures

Serum level of vitamin D
Level of serum vitamin D after 3 month treatment compared to baseline value

Secondary Outcome Measures

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.
Adverse Drug Reactions
Number and severity of adverse drug reactions during treatment
Adherence to medication
Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.

Full Information

First Posted
April 12, 2019
Last Updated
June 3, 2020
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT03920150
Brief Title
Vitamin D 24'000 IU for Oral Intermittent Supplementation
Acronym
DO-IT
Official Title
Vitamin D 24'000 IU for Oral Intermittent Supplementation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2019 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
optimal vitamin D value

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months
Arm Title
IMP
Arm Type
Active Comparator
Arm Description
Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months
Arm Title
IMP + loading dose
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Vi-De 3 Monatsdosis
Intervention Description
Patient will be treated with 3 doses of alcoholic solution for 3 months.
Intervention Type
Drug
Intervention Name(s)
Vitamin D oily capsules
Intervention Description
Patient will be treated with 3 capsules for 3 months.
Intervention Type
Drug
Intervention Name(s)
Vitamin D oily capsules
Intervention Description
Patient will be treated with weekly capsules for an individually calculated number of weeks.
Primary Outcome Measure Information:
Title
Serum level of vitamin D
Description
Level of serum vitamin D after 3 month treatment compared to baseline value
Time Frame
3 months of treatment
Secondary Outcome Measure Information:
Title
Serum level of vitamin D after loading dose
Description
Level of serum vitamin D > 75 nmol/l after an individual number of treatment weeks, calculated with a loading dose formula.
Time Frame
up to 4 months of treatment
Title
Adverse Drug Reactions
Description
Number and severity of adverse drug reactions during treatment
Time Frame
3 months of treatment
Title
Adherence to medication
Description
Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.
Time Frame
3 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: vitamin D deficiency by serum level <50 nmol/l Exclusion Criteria: hypercalcaemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt E Hersberger, Prof
Organizational Affiliation
Pharmaceutical Care Research Group
Official's Role
Study Chair
Facility Information:
Facility Name
Pharmaceutical Care Research Group
City
Basel
ZIP/Postal Code
4056
Country
Switzerland

12. IPD Sharing Statement

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Vitamin D 24'000 IU for Oral Intermittent Supplementation

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