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Oral Vitamin D Substitution Weekly or Monthly and Adherence

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: NCT03141593
Recruitment Status : Completed
First Posted : May 5, 2017
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Drug: Vitamin D: liquid form, start weekly Drug: Vitamin D: liquid form, start monthly Drug: Vitamin D: solid form, start weekly Drug: Vitamin D: solid form, start monthly Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patient will be recruited by their general practitioners (GP) and allocated to the GP's form (liquid or solid). Patients will be randomly assigned to start weekly or monthly intake for 3 months, and switch to the other frequence for 3 more months.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Vitamin D Substitution Weekly or Monthly - Which Procedure Leads to Highest Adherence? A Prospective Intervention Study in Outpatient Care
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : October 31, 2018
Actual Study Completion Date : October 31, 2018

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Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Dekristol


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Serum level of vitamin D [ Time Frame: 3 and 6 months ]
    Level of serum vitamin D compared to baseline value.

  2. Patients preferences [ Time Frame: 3 months of treatment ]
    Questionnaire with 5-point Likert scale (from 1=strongly disagree to 5=strongly agree)


Eligibility Criteria
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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
  • 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
Contacts and Locations
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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): NCT03141593


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 Director: Kurt E Hersberger, Prof University of Basel
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03141593    
Other Study ID Numbers: 2017-00300
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: not decided yet

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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:
adherence to medication
electronic monitoring
Additional relevant MeSH terms:
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Vitamin D Deficiency
Vitamin D
Cholecalciferol
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Ergocalciferols
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents