Vitamin D and COVID-19 Management

NCT ID: NCT04385940

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-19
• Study Completion Date: 2024-07-02

Brief Summary

A novel coronavirus disease 2019 (COVID-19) outbreak is a global dramatic pandemic that is immeasurably impacting the communities. Due to lack of data, symptomatic management is used for COVID-19 infection including oxygen therapy and mechanical ventilation for those with severe infection. Considering immunomodulatory, anti-inflammatory anti-fibrotic and anti-oxidant actions of vitamin D, it's safety and ease of administration, as well as direct effects of vitamin D on immune cell proliferation and activity, pulmonary ACE2 expression and reducing surface tension, evaluation of vitamin D supplementation as an adjuvant therapeutic intervention could be of substantial clinical and economic significance. High prevalence of vitamin D deficiency in elderly, smokers, patients with chronic diseases and excess uptake by adipose tissue in obesity make investigations of its role as a secondary therapeutic agent in COVID-19 conceivable. It should be necessary to monitor serum 25(OH)D levels in all inpatient and outpatient populations with COVID-19 to identify the importance of maintaining or promptly increasing circulating levels of 25(OH)D into the optimal range of 100-150 nmol/L.

The aim of this study is to conduct a double blind, randomized, controlled three weeks clinical trial on the efficacy of vitamin D (daily low dose versus weekly high dose) in COVID-19 patients in order to determine the relationship between baseline vitamin D deficiency and clinical characteristics and to asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery.

Subjects who are randomized to high-dose will be asked to take 50,000 IU for two times during the first week and one dose over second and third weeks to quickly raise their serum levels. Subjects in the low-dose arm will take vitamin D 1000 IU daily for three weeks.

Detailed Description

In-patients

1. Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients.

2. Determine the relationship between baseline vitamin D status and disease severity, laboratory biochemical tests of white blood cell count (WBC), C-reactive protein (CRP), lymphocyte count, leukocytes counts and neutrophil-lymphocyte-ratio (NLR), lactate dehydrogenase, IL-6, IL-1beta, TNF-alpha platelet count, albumin, and serum ferritin, required hospitalization and intensive care unit (ICU) admission.

3. Asses patients' initial response to vitamin D supplementation in week one and determine its association with disease progression and recovery.

4. Compare disease severity and progression, laboratory biochemical tests of white blood cell count (WBC), C-reactive protein (CRP), lymphocyte count, lactate dehydrogenase, IL-6, IL-1beta, TNF-alpha, platelet count, albumin, and serum ferritin, hospital admission and length of stay, duration of mechanical ventilation, hospital mortality and respiratory failure differ between the early responder and non-responder groups.

Out-patients

1. Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients.

2. Determine the relationship between baseline vitamin D deficiency and clinical characteristics.

3. Asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

High dose vitamin D

Ddrops® products,Vitamin D3, 50,000 IU, Oral

Group Type: EXPERIMENTAL

Ddrops® products, 50,000 IU, Oral

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3

Low dose vitamin D

Vitamin D3 1000IU

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 1000IU

Interventions

Ddrops® products, 50,000 IU, Oral

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 1000IU

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

Patients with COVID-19:

• ≥ 17 years old
• Both sexes

Exclusion Criteria

• Patients with dementia, learning disability, mental health needs and alcohol or drug dependency, pregnant women will be excluded.
• Patients with sarcoidosis, hypercalcemia, known vitamin D intolerance

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aldo Montano-Loza, MD, MSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00100606

Identifier Type: -

Identifier Source: org_study_id