Vitamin D 24'000 IU for Oral Intermittent Supplementation

NCT ID: NCT03920150

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-05-31

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DRUG

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

IMP

Vitamin D oily capsules containing 24'000 IU vitamin D for 3 months

Group Type: ACTIVE_COMPARATOR

Vitamin D oily capsules

Intervention Type: DRUG

Patient will be treated with 3 capsules for 3 months.

IMP + loading dose

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.

Group Type: ACTIVE_COMPARATOR

Vitamin D oily capsules

Intervention Type: DRUG

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

Interventions

Vitamin D3

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

Intervention Type: DRUG

Vitamin D oily capsules

Patient will be treated with 3 capsules for 3 months.

Intervention Type: DRUG

Vitamin D oily capsules

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

Intervention Type: DRUG

Other Intervention Names

Vi-De 3 Monatsdosis

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• hypercalcaemia

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt E Hersberger, Prof

Role: STUDY_CHAIR

Pharmaceutical Care Research Group

Locations

Pharmaceutical Care Research Group

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2019-00987

Identifier Type: -

Identifier Source: org_study_id