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Oral Vitamin D Substitution Weekly or Monthly and Adherence

NCT03141593 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2020-02-12

No results posted yet for this study

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

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Kurt E Hersberger, Prof · University of Basel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-09
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141593 on ClinicalTrials.gov