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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

6200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2022-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Covid19 Acute Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention: Lower-dose vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Intervention: Higher-dose vitamin D

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

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes