Oral Vitamin D Substitution Weekly or Monthly and Adherence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2018-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Vitamin D: liquid form, start weekly

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Vitamin D: solid form, start weekly

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Vitamin D: liquid form, start monthly

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Vitamin D: solid form, start monthly

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Vitamin D3 Streuli Vi-De 3 Monatsdosis Dekristolvit D3 Dekristol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No