Vitamin D and COVID-19 Management

Study Overview
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Brief Summary
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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
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In-patients Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients. 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. Asses patients' initial response to vitamin D supplementation in week one and determine its association with disease progression and recovery. 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 Determine the frequency of low serum Vit D levels (<50 nmol/L) in COVID-19 patients. Determine the relationship between baseline vitamin D deficiency and clinical characteristics. Asses patients' response to vitamin D supplementation in week three and determine its association with disease progression and recovery

Official Title
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Improving Vitamin D Status in the Management of COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Dietary Supplement: Ddrops® products, 50,000 IU, Oral
* Dietary Supplement: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High dose vitamin D<br>Ddrops® products,Vitamin D3, 50,000 IU, Oral | Dietary Supplement: Ddrops® products, 50,000 IU, Oral<br>* Vitamin D3<br>|
| Active Comparator: Low dose vitamin D<br>Vitamin D3 1000IU | Dietary Supplement: Vitamin D3<br>* Vitamin D3 1000IU<br>|

What is the study measuring?
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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 |