Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease

Study Overview
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Brief Summary
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COVID-19 caused by SARS-CoV-2 virus has affected the lives of millions of individuals globally and also severely strained the medical community. Pre-symptomatic and asymptomatic SARS-CoV-2 positive individuals far outnumber the symptomatic ones or those with severe disease. The transmission potential of SARS CoV-2 is potentially greater than earlier viral outbreaks of SARS-CoV and MERS-CoV.Routine measures of social distancing, personal hand hygiene and limited outdoor contact activities have shown benefits to limit corona virus infection. However, the role of vitamin D in SARS-CoV-2 infection is sparingly explored despite the knowledge of an immunomodulatory role and protective effect of vitamin D against viral infections. Meta-analysis of five clinical trials of vitamin D supplementation found that those receiving vitamin D supplementation had fewer respiratory tract infections (odds ratio = 0.58 (95%CI, 0.42 - 0.81).Any immune-modulatory effect of vitamin D is likely to be observed at levels which are considered higher than that required for normal bone metabolism.

Official Title
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Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease

Conditions
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Covid19

Intervention / Treatment
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* Drug: cholecalciferol 6 lakh IU


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: RT-PCR proven SARS-CoV-2 infection or computed tomography scan findings compatible with the COVID19 disease (bilateral multifocal ground-glass opacities ≥50%) Moderate to severe COVID-19 defined by PFR ratio of <200 SOFA score>4 Patients with vitamin D deficiency defined as 25 (OH)D level<20 ng/ml Age>18 years Exclusion Criteria: 1. Vitamin D sufficient or already receiving vitamin D supplements 2. Active malignancy 3. Hypercalcemia, hyperparathyroidism 4. Chronic kidney disease (eGFR<30 ml/min) 5. Pregnant and lactating women 6. Patient on mechanical ventilation at ICU admission

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Vitamn D 6 lakh IU oral stat | Drug: cholecalciferol 6 lakh IU<br>* vitamin D levels and serum calcium will be assessed at day 3,7, 14.<br>* Other names: vitamin D;|
| Placebo Comparator: Placebo<br>Placebo equal volume/ weight | Drug: cholecalciferol 6 lakh IU<br>* vitamin D levels and serum calcium will be assessed at day 3,7, 14.<br>* Other names: vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure Assessment (SOFA) | Sequential Organ Failure Assessment score at day 7. SOFA score range from 1 to a maximum of 24. A greator score suggests worse outcome. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequential Organ Failure Assessment (SOFA) Score | Sequential Organ Failure Assessment score at day 3. SOFA score range from 1 to a maximum of 24. A greator score suggests worse outcome. | 3 days | 
| Sequential Organ Failure Assessment (SOFA) score | Sequential Organ Failure Assessment (SOFA) score at day 14. SOFA score range from 1 to a maximum of 24 score. A greator score suggests worse outcome. | 14 days |