Vitamin D 24'000 IU for Oral Intermittent Supplementation

Phase 3

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Vitamin D oily capsules; Drug: Vitamin D3

• Registration Number: NCT03920150
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Group Control, Alcoholic Drinking Solution: 5 ml of an alcoholic drinking solution with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP, Capsules: one capsule with 24'000 IU vitamin D p.o. once a month for 3 months (3 doses).

Group IMP + loading dose, Loading Dose: one capsule with 24'000 IU vitamin D p.o. once a week during an individually calculated number of weeks.

All 3 groups: Measurement of vitamin D in serum before therapy and one week after the last dose.

Study Timeline

• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-18
• Study Start: 2019-09-30
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• vitamin D deficiency by serum level <50 nmol/l

Exclusion Criteria

• hypercalcaemia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMP	Vitamin D oily capsules	Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months
IMP + loading dose	Vitamin D oily capsules	Vitamin D oily capsules containing 24'000 IU vitamin D for an individual number of weeks calculated with the formula: 40 x (100 - actual value \[nmol/l\] x body weight \[kg\] / 24'000 IU.
Control	Vitamin D3	5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months

Primary Outcome Measures

Name	Time	Method
Serum level of vitamin D	3 months of treatment	Level of serum vitamin D after 3 month treatment compared to baseline value

Secondary Outcome Measures

Name	Time	Method
Adherence to medication	3 months of treatment	Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.
Adverse Drug Reactions	3 months of treatment	Number and severity of adverse drug reactions during treatment
Serum level of vitamin D after loading dose	up to 4 months of treatment	Level of serum vitamin D \> 75 nmol/l after an individual number of treatment weeks, calculated with a loading dose formula.

Trial Locations

Locations (1)

Pharmaceutical Care Research Group; 🇨🇭 Basel, Switzerland