Vitamin D 24'000 IU for Oral Intermittent Supplementation (DO-IT)

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Drug: Vitamin D3; Drug: Vitamin D oily capsules; Drug: Vitamin D oily capsules

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • Pharmaceutical Care Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• hypercalcaemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 5 ml alcoholic solution containing 24'000 IU vitamin D for 3 months	Drug: Vitamin D3; Patient will be treated with 3 doses of alcoholic solution for 3 months.; Other Names: Vi-De 3 Monatsdosis
Active Comparator: IMP; Vitamin D oily capsules containing 24'000 IU vitamin D 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum level of vitamin D	Level of serum vitamin D after 3 month treatment compared to baseline value	3 months of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Kurt E Hersberger, Prof, Pharmaceutical Care Research Group

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: optimal vitamin D value
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: 2019-00987

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No