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Short Term, High Dose Vitamin D Supplementation for COVID-19 (SHADE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459247
Recruitment Status : Active, not recruiting
First Posted : July 7, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Ashu Rastogi, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE July 3, 2020
First Posted Date  ICMJE July 7, 2020
Last Update Posted Date August 27, 2020
Actual Study Start Date  ICMJE June 15, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2020)
Virus negativity [ Time Frame: 21 days ]
SARS-CoV-2 RNA negative
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2020)
  • Inflammatory Marker [ Time Frame: 21 days ]
    Change in fibrinogenLevels
  • Inflammatory Marker 2 [ Time Frame: 21 days ]
    Change in D-Dimer Levels
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Term, High Dose Vitamin D Supplementation for COVID-19
Official Title  ICMJE Short Term, High Dose Vitamin D Supplementation for COVID-19 Disease: Double Blind, Controlled, Study
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.

Detailed Description

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.[6] 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.

Methods: Consecutive individuals with SARS-CoV-2 infection who were mildly symptomatic or asymptomatic with or without co-morbidities (hypertension, diabetes mellitus, chronic obstructive airway disease, chronic liver disease) admitted to tertiary care hospital in north India were invited for the study. A written consent was obtained from all patients included in the study and protocol was approved by the Institute Ethics Committee.

Patients with vitamin D deficiency defined as 25 (OH)D level<20 ng/ml were randomized to receive daily 60,000IU of cholecalciferol (5 ml oral solution in nano droplet form) for seven days in the "intervention arm" or to receive a single dose of 60,000 IU vitamin D supplementation at admission in the "control arm". Patients unable to take oral supplementation like those requiring invasive ventilation were excluded. Subsequently, 25(OH)D levels were assessed at day 7 and a weekly supplementation of 60,000IU provided to those with 25(OH)D >50 ng/ml or continued on daily vitamin D 60,000 IU supplementation for another seven days in participants with 25 (OH)D<50ng/ml (day-14) in the intervention arm. No vitamin D supplementation was provided in the control arm other than the initial dose at hospital admission.

25 (OH)D, serum calcium, phosphorus, fibrinogen , d-dimer, C-reactive protein, procalcitonin, renal and liver function tests were performed periodically up till day-21 or virus negativity, whichever occurred earlier. Oro-pharyngeal swabs were obtained for SARS-CoV-2 RNA detection at day-5, 7, 10, 14, 18 and 21 and detection was performed by real-time polymerase chain reaction (RT-PCR), CFX-96 IVD, Bio-Rad. 25 (OH)D was analysed by electrochemiluminescence immunoassay (ECLIA) (Roche Cobas E 801 Analyzer; Roche Diagnostics), using the kit supplied by the same manufacturer (Elecsys Total Vitamin D, version 2.0). Serum calcium (N, 8.5-10.2 mg/dl) and C-reactive protein (N, 0-5 mg/l) were processed by ECLIA method using Roche Cobas 8000, Roche Diagnostics. D dimer (N, 0-240 ng/ml) & fibrinogen (N, 2-4g/l) were analyzed using Stago Compact/ Stago STA R model, Diagnostica Stago, Inc, USA respectively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE COVID
Intervention  ICMJE Drug: Vit D
Oral liquid formulation of 60000 IU
Study Arms  ICMJE
  • Experimental: Intervention
    Vitamin D high dose
    Intervention: Drug: Vit D
  • No Intervention: Control arm
    No Vitamin D supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 10, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • SARS-CoV-2 RNA positive Asymptomatic individuals

Exclusion Criteria:

  • Uncontrolled Diabetes Uncontrolled Hypertension Chronic Liver Disease Chronic obstructive Pulmonary disease Requiring Invasive Ventilation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04459247
Other Study ID Numbers  ICMJE 121/20
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ashu Rastogi, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP