NCT04459247

Brief Summary

Coronavirus-2019 (COVID-19) caused by severe acute respiratory syndrome-associated coronavirus-2 (SARS-CoV-2) has affected the lives of millions of individuals globally and 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 greator than earlier viral outbreaks of SARS-CoV and MERS-CoV. Identification of asymptomatic carriers of SARS-CoV-2 infection is paramount to contain viral infection because of high transmission potential 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 not explored despite the knowledge of an immunomodulatory role and protective effect of vitamin D against viral infections. It has been found that mortality from COVID-19 is more in countries with vitamin D deficiency. The role of therapeutic vitamin D supplementation in asymptomatic individuals with vitamin-D deficiency and COVID-19 is not known. Immune-modulatory effect of vitamin D is likely to be observed at 25(OH)D levels which are considered higher than that required for normal bone metabolism.An earlier SARS-CoV-2 negativity may have significant public health benefits in limiting the spread of the disease. Therefore, we hypothesise that high dose vitamin D supplementation in patients with COVID-19 and vitamin D deficiency may lead to SARS-CoV-2 negativity in greater proportions of patients associated with decrease in serological markers of inflammation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

June 15, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2021

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

July 3, 2020

Last Update Submit

October 30, 2021

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • Virus negativity

    SARS-CoV-2 RNA negative

    21 days

Secondary Outcomes (2)

  • Inflammatory Marker

    21 days

  • Inflammatory Marker 2

    21 days

Study Arms (2)

Intervention

EXPERIMENTAL

Vitamin D high dose

Drug: Vit D

Control arm

NO INTERVENTION

No Vitamin D supplementation

Interventions

Vit DDRUG

Oral liquid formulation of 60000 IU

Intervention

Eligibility Criteria

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

You may qualify if:

  • SARS-CoV-2 RNA positive Asymptomatic individuals

You may not qualify if:

  • Uncontrolled Diabetes Uncontrolled Hypertension Chronic Liver Disease Chronic obstructive Pulmonary disease Requiring Invasive Ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deptt of Endocrinology

Chandigarh, 160012, India

Location

Related Publications (2)

  • Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043.

    PMID: 34029377DERIVED

  • Rastogi A, Bhansali A, Khare N, Suri V, Yaddanapudi N, Sachdeva N, Puri GD, Malhotra P. Short term, high-dose vitamin D supplementation for COVID-19 disease: a randomised, placebo-controlled, study (SHADE study). Postgrad Med J. 2022 Feb;98(1156):87-90. doi: 10.1136/postgradmedj-2020-139065. Epub 2020 Nov 12.

    PMID: 33184146DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 3, 2020

First Posted

July 7, 2020

Study Start

June 15, 2020

Primary Completion

March 30, 2021

Study Completion

April 10, 2021

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)