NCT04579640

Brief Summary

CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,200

participants targeted

Target at P75+ for phase_3 covid19

Timeline
Completed

Started Oct 2020

Typical duration for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 6, 2022

Status Verified

June 1, 2021

Enrollment Period

8 months

First QC Date

October 6, 2020

Last Update Submit

March 28, 2022

Conditions

Covid19Acute Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.

    Over 6 months

Secondary Outcomes (22)

  • Proportion of participants developing PCR- or antigen test-positive COVID-19

    Over 6 months

  • Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection

    Over 6 months

  • Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment

    Over 6 months

  • Proportion of participants with COPD who experience one or more exacerbations of COPD requiring treatment with oral corticosteroids and/or antibiotics, and/or requiring hospital treatment

    Over 6 months

  • Proportion of participants who have had PCR-, antigen test- or antibody test-confirmed SARS-CoV-2 infection who report symptoms of COVID-19 lasting more than 4 weeks after onset

    Over 6 months

  • +17 more secondary outcomes

Study Arms (3)

Control

NO INTERVENTION

Standard of care (national recommendation of 400 IU/day vitamin D)

Intervention: Lower-dose vitamin D

EXPERIMENTAL

Offer of a daily dose of 800 IU (20 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level \<75 nmol/L

Dietary Supplement: Vitamin D

Intervention: Higher-dose vitamin D

EXPERIMENTAL

Offer of a daily dose of 3200 IU (80 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level \<75 nmol/L

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT

Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol

Intervention: Higher-dose vitamin DIntervention: Lower-dose vitamin D

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • UK resident
  • Age ≥16 years
  • Gives informed consent to participate

You may not qualify if:

  • taking digoxin, alfacalcidol, calcitriol, dihydrotachysterol or paricalcitol
  • known diagnosis of sarcoidosis, primary hyperparathyroidism, renal stones or renal failure requiring dialysis
  • known allergy to any ingredient in the study capsules (vitamin D, olive oil, caramel, gelatine or glycerol)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary University of London

London, County (optional), E1 2AB, United Kingdom

Location

Related Publications (1)

  • Jolliffe DA, Holt H, Greenig M, Talaei M, Perdek N, Pfeffer P, Vivaldi G, Maltby S, Symons J, Barlow NL, Normandale A, Garcha R, Richter AG, Faustini SE, Orton C, Ford D, Lyons RA, Davies GA, Kee F, Griffiths CJ, Norrie J, Sheikh A, Shaheen SO, Relton C, Martineau AR. Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT). BMJ. 2022 Sep 7;378:e071230. doi: 10.1136/bmj-2022-071230.

    PMID: 36215226DERIVED

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 8, 2020

Study Start

October 27, 2020

Primary Completion

June 17, 2021

Study Completion

February 28, 2022

Last Updated

April 6, 2022

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

GB(1)