Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
Study NCT ID:
NCT03920150
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2019-04-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vitamin D 24'000 IU for Oral Intermittent Supplementation
Sponsor:
University Hospital, Basel, Switzerland
Organization:
Study Overview
Official Title:
Vitamin D 24'000 IU for Oral Intermittent Supplementation
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DO-IT
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: