NCT05037253

COVID-19 Morbidity in Healthcare Workers and Vitamin D Supplementation

Completed Phase 4 Last updated 8 September 2021

What this trial tests

Phase 4 trial testing Vitamin D in COVID-19 Respiratory Infection in 128 participants. Completed in 30 May 2021.

Timeline

30 October 2020

Primary endpoint
30 May 2021

30 May 2021

Quick facts

Lead sponsor	Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	128
Start date	30 October 2020
Primary completion	30 May 2021
Estimated completion	30 May 2021
Sites	1 location across Russia

Drugs / interventions tested

• Vitamin D

Conditions studied

• COVID-19 Respiratory Infection — all drugs for COVID-19 Respiratory Infection →

Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Who can join

Adults 18 to 65, any sex, with COVID-19 Respiratory Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

\[Aim\] Purpose of the study: to analyze the effect of vitamin D supplementation in reducing COVID-19 morbidity and severity in healthcare workers.

The study will involve a minimum of 120 medical staff. All participants in the study will assess twice for serum 25(OH)D level: baseline and after 3 months of Vitamin D supplementation. After the baseline examination, the subjects will be randomized into 2 groups. In the first (No. 1), vitamin D therapy will initiate at a dosage of 50,000 IU on the first and second week, followed by a switch to a daily intake of 5,000 IU for 3 months. In the second group (No. 2), vitamin D therapy will prescribe for 3 months at a dosage of 2,000 IU/day. After 3 months of vitamin D supplementation, all participants will undergo to repeat testing of serum 25(OH)D level with an assessment of the effectiveness of the therapy. Body mass index (BMI), height, weight, SARS-CoV-2 antibodies (IgG), 25-hydroxycalciferol (25(OH)D) and presence of acute viral infection futures, parameters assessed after treatment.

Publications & conference data

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

1. Vitamin D Intake May Reduce SARS-CoV-2 Infection Morbidity in Health Care Workers.
   Karonova TL, Chernikova AT, Golovatyuk KA, Bykova ES, et al · · 2022 · cited 23× · PMID 35276863 · DOI 10.3390/nu14030505