search
Back to results

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

Primary Purpose

Covid19

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
cholecalciferol 6 lakh IU
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Deptt of Endocrinology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

Vitamn D 6 lakh IU oral stat

Placebo equal volume/ weight

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 8, 2021
Last Updated
December 19, 2021
Sponsor
Postgraduate Institute of Medical Education and Research
search

1. Study Identification

Unique Protocol Identification Number
NCT04952857
Brief Title
Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease
Acronym
SHADE-S
Official Title
Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Vitamn D 6 lakh IU oral stat
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo equal volume/ weight
Intervention Type
Drug
Intervention Name(s)
cholecalciferol 6 lakh IU
Other Intervention Name(s)
vitamin D
Intervention Description
vitamin D levels and serum calcium will be assessed at day 3,7, 14.
Primary Outcome Measure Information:
Title
Sequential Organ Failure Assessment (SOFA)
Description
Sequential Organ Failure Assessment score at day 7. SOFA score range from 1 to a maximum of 24. A greator score suggests worse outcome.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Sequential Organ Failure Assessment (SOFA) Score
Description
Sequential Organ Failure Assessment score at day 3. SOFA score range from 1 to a maximum of 24. A greator score suggests worse outcome.
Time Frame
3 days
Title
Sequential Organ Failure Assessment (SOFA) score
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Deptt of Endocrinology
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs