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

Sponsor
Postgraduate Institute of Medical Education and Research (Other)
Overall Status
Completed
CT.gov ID
NCT04952857
Collaborator
(none)
90
Enrollment
1
Location
2
Arms
4.3
Actual Duration (Months)
20.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: cholecalciferol 6 lakh IU
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Short Term, High Dose Vitamin D Supplementation in Moderate to Severe COVID-19 Disease
Actual Study Start Date :
Aug 1, 2021
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Vitamn D 6 lakh IU oral stat

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

    		•
    Placebo Comparator: Placebo

    Placebo equal volume/ weight

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deptt of Endocrinology Chandigarh India 160012

    Sponsors and Collaborators

    • Postgraduate Institute of Medical Education and Research

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ashu Rastogi, Associate Professor, Postgraduate Institute of Medical Education and Research
    ClinicalTrials.gov Identifier:
    NCT04952857
    Other Study ID Numbers:
    • INT/2020/001068
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    COVID-19
    Vitamin D
    Cholecalciferol

    Study Results

    No Results Posted as of Dec 21, 2021