Vitamin D 24'000 IU for Oral Intermittent Supplementation

Vitamin D Deficiency Clinical Trial

— DO-IT  

Official title:

Vitamin D 24'000 IU for Oral Intermittent Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920150
• Other study ID #: 2019-00987
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• hypercalcaemia

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3
Patient will be treated with 3 doses of alcoholic solution for 3 months.
• Vitamin D oily capsules
Patient will be treated with 3 capsules for 3 months.
• Vitamin D oily capsules
Patient will be treated with weekly capsules for an individually calculated number of weeks.

Locations

Country	Name	City	State
Switzerland	Pharmaceutical Care Research Group	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum level of vitamin D	Level of serum vitamin D after 3 month treatment compared to baseline value	3 months of treatment
Secondary	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
Secondary	Adverse Drug Reactions	Number and severity of adverse drug reactions during treatment	3 months of treatment
Secondary	Adherence to medication	Taking adherence: (number of doses taken) divided by (number of doses prescribed) x 100.	3 months of treatment