Vitamin D and COVID-19 Management

COVID-19 Clinical Trial

Official title:

Improving Vitamin D Status in the Management of COVID-19

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04385940
• Other study ID #: Pro00100606
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 19, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Dietary Supplement:
• Ddrops® products, 50,000 IU, Oral
Vitamin D3
• Vitamin D3
Vitamin D3 1000IU

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms recovery	Number of Participants whose symptoms recovered over three weeks	Time from onset of intervention to day 21
Secondary	Hospitalization	Number of patients who required hospitalization	Between diagnosis and day 21
Secondary	Blood white blood cell count (WBC)	x 109/L	At day 0 before starting intervention and day 21 of intervention
Secondary	Duration of mechanical ventilation	If patients required mechanical ventilation at any time after diagnosis	Between diagnosis and day 21
Secondary	Duration of hospitalization	Length of stay in hospital (days)	Between diagnosis and day 21
Secondary	Intensive care unit (ICU) admission	Number of patients who required ICU	Between diagnosis and day 21
Secondary	Duration of ICU stay	Length of stay in ICU	Between diagnosis and day 21
Secondary	Blood C-reactive protein (CRP)	mg/L	Baseline and day 21
Secondary	Blood Lymphocyte count	number of lymphocytes in 1 microliter (µL) of blood	Baseline and day 21
Secondary	Blood Ferritin	ng/mL	Baseline and day 21
Secondary	Blood platelet count	platelets per microliter of blood	Baseline and day 21
Secondary	Blood interleukin-6 (IL-6)	pg/mL	Baseline and day 21
Secondary	Blood Tumor Necrosis Factor alpha (TNF)	pg/ml	Baseline and day 21