NCT04952857

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_4 covid19

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

June 8, 2021

Last Update Submit

December 19, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Sequential Organ Failure Assessment (SOFA) Score

    3 days

  • Sequential Organ Failure Assessment (SOFA) score

    14 days

Study Arms (2)

Intervention

EXPERIMENTAL

Vitamn D 6 lakh IU oral stat

Drug: cholecalciferol 6 lakh IU

Placebo

PLACEBO COMPARATOR

Placebo equal volume/ weight

Drug: cholecalciferol 6 lakh IU

Interventions

cholecalciferol 6 lakh IUDRUG

vitamin D levels and serum calcium will be assessed at day 3,7, 14.

Also known as: vitamin D
InterventionPlacebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deptt of Endocrinology

Chandigarh, 160012, India

Location

Related Publications (1)

  • Singh A, Rastogi A, Puri GD, Ganesh V, Naik NB, Kajal K, Kahlon S, Soni SL, Kaloria N, Saini K, Hazarika A, Mahajan V, Singla K, Bhadada S, Soni V. Therapeutic high-dose vitamin D for vitamin D-deficient severe COVID-19 disease: randomized, double-blind, placebo-controlled study (SHADE-S). J Public Health (Oxf). 2024 May 29;46(2):256-266. doi: 10.1093/pubmed/fdae007.

    PMID: 38291897DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2021

First Posted

July 7, 2021

Study Start

August 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 10, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations

IN(1)