Vitamin D and COVID-19 Management

• ClinicalTrials.gov Identifier: NCT04385940
• Recruitment Status: Recruiting
• First Posted: May 13, 2020
• Last Update Posted: April 20, 2023
• Sponsor: University of Alberta
• Information provided by (Responsible Party): University of Alberta

Study Description

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.

Condition or disease	Intervention/treatment	Phase
COVID-19	Dietary Supplement: Ddrops® products, 50,000 IU, Oral; Dietary Supplement: Vitamin D3	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Vitamin D Status in the Management of COVID-19
• Actual Study Start Date: March 19, 2021
• Estimated Primary Completion Date: October 31, 2023
• Estimated Study Completion Date: October 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Symptoms recovery [ Time Frame: Time from onset of intervention to day 21 ]
   Number of Participants whose symptoms recovered over three weeks

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Aldo Montano-Loza, MD, MSc, PhD; 780 248-1892; montanol@ualberta.ca

Locations

Canada, Alberta

University of Alberta; Recruiting

Edmonton, Alberta, Canada, T6G 2R3

Contact: Aldo Montano-Loza, MD, MSc, PhD 780 248-1892 montanol@ualberta.ca

Sponsors and Collaborators

University of Alberta

Investigators

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

More Information

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT04385940
• Other Study ID Numbers: Pro00100606
• First Posted: May 13, 2020
• Last Update Posted: April 20, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents