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

Covid19 Clinical Trial

— SHADE-S  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04952857
• Other study ID #: INT/2020/001068
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: December 2021
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 10, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. RT-PCR proven SARS-CoV-2 infection or computed tomography scan findings compatible with the COVID19 disease (bilateral multifocal ground-glass opacities =50%)

2. Moderate to severe COVID-19 defined by PFR ratio of <200

3. SOFA score>4

4. Patients with vitamin D deficiency defined as 25 (OH)D level<20 ng/ml

5. 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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• cholecalciferol 6 lakh IU
vitamin D levels and serum calcium will be assessed at day 3,7, 14.

Locations

Country	Name	City	State
India	Deptt of Endocrinology	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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