Trial of Vitamin D to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections (CORONAVIT)

Queen Mary University of London

Status and phase: Completed; Phase 3

Conditions: Covid19; Acute Respiratory Tract Infection

Treatments: Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04579640

289515

Details and patient eligibility

About

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.

Enrollment: 6,200 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. UK resident
2. Age ≥16 years
3. Gives informed consent to participate

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,200 participants in 3 patient groups

Control

No Intervention group

Description:

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

Intervention: Lower-dose vitamin D

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D

Intervention: Higher-dose vitamin D

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin D