COVID-19 Morbidity in Healthcare Workers and Vitamin D Supplementation

NCT05037253 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2021-09-08

No results posted yet for this study

Summary

\[Aim\] 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.

Conditions

  • COVID-19 Respiratory Infection

Interventions

DRUG

Vitamin D

Patients will be randomised to receive either high dose vitamin D (50,000 IU weekly) on the first and second week, followed by a switch to a daily intake of 5,000 IU for 3 months or low dose vitamin D (2,000 IU weekly) for 3 months.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-30
Primary Completion
2021-05-30
Completion
2021-05-30

Countries

  • Russia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05037253 on ClinicalTrials.gov