Oral Vitamin D Substitution Weekly or Monthly and Adherence

February 10, 2020 updated by: University Hospital, Basel, Switzerland

Oral Vitamin D Substitution Weekly or Monthly - Which Procedure Leads to Highest Adherence? A Prospective Intervention Study in Outpatient Care

Vitamin D deficiency (defined as 25(OH)-vitamin D serum level <50 nmol/l) is cured with supplementation by mouth. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Commercially available pharmaceutical forms are liquid in Switzerland (drops) and solid forms in Germany (tablets and capsules). Because therapeutic range of vitamin D3 is wide and toxicity is seldom reached, even after the consumption of 200'000 IU, and because the administration of 8 drops daily is inconvenient, weekly and monthly administrations of the cumulative amount (i.e., 5'600 IU weekly or 24'000 IU monthly) have been investigated. Both administration schedules are therapeutic equivalent. The study aims to investigate which form (liquid or solid) and which schedule (weekly or monthly) procure the highest adherence behavior with outpatients under polypharmacy i.e., with 4 or more medications daily. The investigators will use commercially available Swiss and German products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intervention study in patients with serum vitamin D <50 nmol/l and polypharmacy, defined as ≥4 medicaments/day. Treatment duration: 6 months. Treatment groups are defined as Lm (liquid monthly 24'000 IU); Lw (liquid weekly 5'600 IU); Sm (solid monthly 20'000 IU) and Sw (solid weekly 5'600 IU). Cross-over design with identical form (liquid or solid) and switching frequence, i.e. from weekly to monthly treatment and vice versa, for 3 months each.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4056
        • Pharmaceutical Care Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • vitamin D deficiency by serum level <50 nmol/l
  • polypharmacy defined as 4 daily medicines or more
  • speaking German or Swiss German

Exclusion Criteria:

  • hypercalcaemia
  • substitution treatment with cholecalciferol in the past 3 months
  • medication intake provided by a third person and not by the patient himself

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D: liquid form, start weekly
5'600 IU weekly (1.4 ml oily drops) start for 3 months, will cross-over to 24'000 IU monthly (5 ml alcoholic drops) for the following 3 months.
Drug: Vitamin D: liquid form, start weekly
Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.
Other Names:
  • Vitamin D3 Streuli
Active Comparator: Vitamin D: solid form, start weekly
5'600 IU weekly (1 soft capsule) start for 3 months, will cross-over to 20'000 IU monthly (1 tablet) for the following 3 months.
Drug: Vitamin D: solid form, start weekly
Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.
Other Names:
  • Dekristolvit D3
Active Comparator: Vitamin D: liquid form, start monthly
24'000 IU monthly (5 ml alcoholic drops) start for 3 months, will cross-over to 5'600 IU weekly (1.4 ml oily drops) for the following 3 months.
Drug: Vitamin D: liquid form, start monthly
Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.
Other Names:
  • Vi-De 3 Monatsdosis
Active Comparator: Vitamin D: solid form, start monthly
20'000 IU monthly (1 tablet) start for 3 months, will cross-over to 5'600 IU weekly (1 soft capsule) for the following 3 months.
Drug: Vitamin D: solid form, start monthly
Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.
Other Names:
  • Dekristol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to medication
Time Frame: 3 months of treatment
Taking adherence: number of dosis taken divided by number of dosis prescribed. Timing adherence: number of dosis taken within a time interval (within 15% of the mean preset intake time) divided by number of dosis prescribed.
3 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum level of vitamin D
Time Frame: 3 and 6 months
Level of serum vitamin D compared to baseline value.
3 and 6 months
Patients preferences
Time Frame: 3 months of treatment
Questionnaire with 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)
3 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Director: Kurt E Hersberger, Prof, University of Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2017

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-00300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

not decided yet

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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