Vitamin D 24'000 IU for Oral Intermittent Supplementation

NCT03920150 | Completed Phase 3

• 1 other identifier: 2019-00987
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Keywords

optimal vitamin D value

Outcome Measures

Primary Outcomes (1)

• Serum level of vitamin D

  Level of serum vitamin D after 3 month treatment compared to baseline value

  3 months of treatment

Secondary Outcomes (3)

• Serum level of vitamin D after loading dose

  up to 4 months of treatment

• Adverse Drug Reactions

  3 months of treatment

• Adherence to medication

  3 months of treatment

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Drug: Vitamin D3

IMP

ACTIVE COMPARATOR

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

Drug: Vitamin D oily capsules

IMP + loading dose

ACTIVE COMPARATOR

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.

Drug: Vitamin D oily capsules

Interventions

Vitamin D3 DRUG

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

Also known as: Vi-De 3 Monatsdosis

Control

Vitamin D oily capsules DRUG

Patient will be treated with 3 capsules for 3 months.

IMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• hypercalcaemia

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Pharmaceutical Care Research Group

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Kurt E Hersberger, Prof

  Pharmaceutical Care Research Group

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient will be recruited by their general practitioner. Patients will be randomly assigned to be supplemented with monthly solution (control group), monthly capsules (IMP group) or weekly capsules after calculation of a individual loading dose (IMP + loading dose group).

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 18, 2019
• Study Start: September 30, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

CH (1)