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Vitamin D 24'000 IU for Oral Intermittent Supplementation

NCT03920150 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2020-06-04

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 oral supplementation. National guidelines recommend the administration of 800 IU cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). Cumulative intermittent administration monthly (24'000 IU) or weekly (5'600 IU) is possible. Commercially available intermittent pharmaceutical forms in Switzerland are liquid (oily or alcoholic solution). The study aims to compare the rise of vitamin D3 levels after treatment between newly developed soft capsules and monthly solution (primary outcome), and to evaluate the effect of a loading dose (without infringing the cumulative maximal dose of 4'000 IU per day) on the achievement of optimal values \>75 nmol/l (secondary outcome). The investigators will use newly developed soft capsules and alcoholic solution, which are commercially available in Switzerland.

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

Vitamin D3

Patient will be treated with 3 doses of alcoholic solution for 3 months.

DRUG

Vitamin D oily capsules

Patient will be treated with 3 capsules for 3 months.

DRUG

Vitamin D oily capsules

Patient will be treated with weekly capsules for an individually calculated number of weeks.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Kurt E Hersberger, Prof · Pharmaceutical Care Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-05-31
Completion
2020-05-31

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 NCT03920150 on ClinicalTrials.gov