Vitamin D and COVID-19 Management

Improving Vitamin D Status in the Management of COVID-19

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Dietary supplement: Ddrops® products, 50,000 IU, Oral; Dietary supplement: Vitamin D3

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

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2R3
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose vitamin D; Ddrops® products,Vitamin D3, 50,000 IU, Oral	Dietary supplement: Ddrops® products, 50,000 IU, Oral; Vitamin D3
Active Comparator: Low dose vitamin D; Vitamin D3 1000IU	Dietary supplement: Vitamin D3; Vitamin D3 1000IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms recovery	Number of Participants whose symptoms recovered over three weeks	Time from onset of intervention to day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	Number of patients who required hospitalization	Between diagnosis and day 21
Blood white blood cell count (WBC)	x 109/L	At day 0 before starting intervention and day 21 of intervention
Duration of mechanical ventilation	If patients required mechanical ventilation at any time after diagnosis	Between diagnosis and day 21
Duration of hospitalization	Length of stay in hospital (days)	Between diagnosis and day 21
Intensive care unit (ICU) admission	Number of patients who required ICU	Between diagnosis and day 21
Duration of ICU stay	Length of stay in ICU	Between diagnosis and day 21
Blood C-reactive protein (CRP)	mg/L	Baseline and day 21
Blood Lymphocyte count	number of lymphocytes in 1 microliter (µL) of blood	Baseline and day 21
Blood Ferritin	ng/mL	Baseline and day 21
Blood platelet count	platelets per microliter of blood	Baseline and day 21
Blood interleukin-6 (IL-6)	pg/mL	Baseline and day 21
Blood Tumor Necrosis Factor alpha (TNF)	pg/ml	Baseline and day 21

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Aldo Montano-Loza, MD, MSc, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2021
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 22, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Cholecalciferol
• Other Study ID Numbers: Pro00100606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No