Last reviewed · How we verify

NCT03920150: DO-IT

Vitamin D 24'000 IU for Oral Intermittent Supplementation

Completed Phase 3 Last updated 4 June 2020
What this trial tests

Phase 3 trial testing Vitamin D3 in Vitamin D Deficiency in 58 participants. Completed in 31 May 2020.

Timeline
30 September 2019
Primary endpoint
31 May 2020
31 May 2020

Quick facts

Lead sponsorUniversity Hospital, Basel, Switzerland
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment58
Start date30 September 2019
Primary completion31 May 2020
Estimated completion31 May 2020
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital, Basel, Switzerland

Who can join

18 and older, any sex, with Vitamin D Deficiency. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Vitamin D oral intermittent treatment (DO IT) study, a randomized clinical trial with individual loading regimen.
    Rothen JP, Rutishauser J, Walter PN, Hersberger KE, et al · · 2021 · cited 4× · PMID 34548526 · DOI 10.1038/s41598-021-97417-x

Verify or expand the search:

Other trials of Vitamin D3

Trials testing the same drug.

Other recruiting trials for Vitamin D Deficiency

Currently open trials in the same condition.

Other University Hospital, Basel, Switzerland trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03920150.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing