Oral Vitamin D Substitution Weekly or Monthly and Adherence

NCT03141593 | Completed Phase 4

• 1 other identifier: 2017-00300
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

adherence to medication; electronic monitoring

Outcome Measures

Primary Outcomes (1)

• Adherence to medication

  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 Outcomes (2)

• Serum level of vitamin D

  3 and 6 months

• Patients preferences

  3 months of treatment

Study Arms (4)

Vitamin D: liquid form, start weekly

ACTIVE COMPARATOR

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

Vitamin D: solid form, start weekly

ACTIVE COMPARATOR

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

Vitamin D: liquid form, start monthly

ACTIVE COMPARATOR

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

Vitamin D: solid form, start monthly

ACTIVE COMPARATOR

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

Interventions

Vitamin D: liquid form, start weekly DRUG

Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.

Also known as: Vitamin D3 Streuli

Vitamin D: liquid form, start weekly

Vitamin D: liquid form, start monthly DRUG

Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.

Also known as: Vi-De 3 Monatsdosis

Vitamin D: liquid form, start monthly

Vitamin D: solid form, start weekly DRUG

Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.

Also known as: Dekristolvit D3

Vitamin D: solid form, start weekly

Vitamin D: solid form, start monthly DRUG

Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.

Also known as: Dekristol

Vitamin D: solid form, start monthly

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Pharmaceutical Care Research Group

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Kurt E Hersberger, Prof

  University of Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: May 5, 2017
• Study Start: October 9, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)