Clinical trial NCT04385940: Vitamin D and COVID-19 Management
Official title: Improving Vitamin D Status in the Management of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 11
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Symptoms recovery
timeFrame: Time from onset of intervention to day 21
Secondary outcomes:
measure: Hospitalization
timeFrame: Between diagnosis and day 21
measure: Blood white blood cell count (WBC)
timeFrame: At day 0 before starting intervention and day 21 of intervention
measure: Duration of mechanical ventilation
timeFrame: Between diagnosis and day 21
measure: Duration of hospitalization
timeFrame: Between diagnosis and day 21
measure: Intensive care unit (ICU) admission
timeFrame: Between diagnosis and day 21
measure: Duration of ICU stay
timeFrame: Between diagnosis and day 21
measure: Blood C-reactive protein (CRP)
timeFrame: Baseline and day 21
measure: Blood Lymphocyte count
timeFrame: Baseline and day 21
measure: Blood Ferritin
timeFrame: Baseline and day 21
measure: Blood platelet count
timeFrame: Baseline and day 21
measure: Blood interleukin-6 (IL-6)
timeFrame: Baseline and day 21
measure: Blood Tumor Necrosis Factor alpha (TNF)
timeFrame: Baseline and day 21
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Aldo Montano-Loza, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: