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

Phase 4

Completed

• Conditions: Covid19
• Interventions: Drug: cholecalciferol 6 lakh IU

• Registration Number: NCT04952857
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-07-03
• Study First Posted: 2021-07-07
• Study Start: 2021-08-01
• Primary Completion: 2021-11-30
• Status Verified: 2021-12
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-19
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	cholecalciferol 6 lakh IU	Vitamn D 6 lakh IU oral stat
Placebo	cholecalciferol 6 lakh IU	Placebo equal volume/ weight

Primary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA)	7 days	Sequential Organ Failure Assessment score at day 7. SOFA score range from 1 to a maximum of 24. A greator score suggests worse outcome.

Secondary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) Score	3 days	Sequential Organ Failure Assessment score at day 3. SOFA score range from 1 to a maximum of 24. A greator score suggests worse outcome.
Sequential Organ Failure Assessment (SOFA) score	14 days	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.

Trial Locations

Locations (1)

Deptt of Endocrinology; 🇮🇳 Chandigarh, India