Oral Vitamin D Substitution Weekly or Monthly and Adherence

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141593
• Other study ID #: 2017-00300
• Status: Completed
• Phase: Phase 4
• Start date: October 9, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Switzerland	Pharmaceutical Care Research Group	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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