High dose Vitamin D in Preventing Aggravation of COVID-19

Preventing Disease Aggravation in COVID-19 by high dose Vitamin D: a randomized trial (COVIT-D) - COVIT-D

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001793-30-DK

Enrollment

480

Registered

2020-05-24

Start date

2020-07-01

Completion date

Unknown

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-COV-2 positive patients MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862 MedDRA version: 20.0 Level: PT Classification code 10050713 Term: Vitamin D System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: LLT Classification code 10013097 Term: Disease aggravation System Organ Class: 100000004867

Interventions

Trade Name: Benferol Pharmaceutical Form: Capsule, soft INN or Proposed INN: Cholecalciferol Other descriptive name: CHOLECALCIFEROL CONCENTRATE Concentration unit: IU international unit(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Age>=50 years 2 Positive test for SARS-COV-2 3 Signed informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 380

Exclusion criteria

Exclusion criteria: 1) Need for immediate hospital admission 2) Known hypercalcemia or hyperparathyroidism 3) Significant kidney disease needing dialysis 4) Known kidney stone or nephrocalcinosis 5) Pregnancy or no-anti-conception in fertile women* 6) Regular user of supplemental Vitamin D (>=20 µg /day > one month) or 7) Known intolerance to Vitamin D

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether treatment with a single high-dose of Vitamin D3 25000 IU (625µg) versus placebo in SARS-COV-2 positive patients, will reduce disease-aggravation defined as need for hospital-admission and duration of hospitalization or death in home-based patients.;Secondary Objective: Not applicable;Primary end point(s): Disease aggravation defined as: Combined endpoint of death and duration of hospitalization, calculated as Days Alive and Out of Hospital (DAOH) in a Time Frame of 6 weeks (42 days). ;Timepoint(s) of evaluation of this end point: 6 weeks (42 days)	—

Measure

Time frame

Main Objective: To investigate whether treatment with a single high-dose of Vitamin D3 25000 IU (625µg) versus placebo in SARS-COV-2 positive patients, will reduce disease-aggravation defined as need for hospital-admission and duration of hospitalization or death in home-based patients.;Secondary Objective: Not applicable;Primary end point(s): Disease aggravation defined as: Combined endpoint of death and duration of hospitalization, calculated as Days Alive and Out of Hospital (DAOH) in a Time Frame of 6 weeks (42 days). ;Timepoint(s) of evaluation of this end point: 6 weeks (42 days)

—

Secondary

Measure	Time frame
Secondary end point(s): a) Rate of combined death or hospitalization b) All-cause mortality c) Percentage of “ended infection” in the first month after inclusion (: “recovered” COVID-19 - according to the definition of Statens Serum Institute (SSI)). ;Timepoint(s) of evaluation of this end point: 6 weeks (42 days)	—

Countries

Denmark

Contacts

Public ContactAhmad Sajadieh

Department of Cardiologi, Copenhagen University Hospital of Bispebjerg

ahmad.sajadieh@regionh.dk+4531480483

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026