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Effect of vitamin D supplementation in diagnosed cases of 2019 Novel Coronavirus; a randomized clinical trial

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History
# Registration date Revision Id
2 2021-07-05, 1400/04/14 189204
1 2020-07-05, 1399/04/15 141882
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  • Protocol summary

    Interventions in three groups will be performed as below: Group 1: 50000 International Unit (IU) vitamin D supplementation weekly Group 2: 5,000 IU vitamin D supplementation daily Group 3: 1000 IU vitamin D supplementation daily Blood samples will be taken before and after the intervention. This study will be done in Mashhad-Iran. Blinding will be performed for patients and investigators.
    Interventions in three groups will be performed as below: Group 1: 50000 International Unit (IU) vitamin D supplementation and then 10000 IU supplementation daily Group 2: 1000 IU vitamin D supplementation daily Blood samples will be taken before and after the intervention. This study will be done in Mashhad-Iran. Blinding will be performed for patients and investigators.
    مداخله در 3 گروه به شرح زیر انجام خواهد شد: گروه 1: 50000 واحد بین الملل مکمل ویتامین دی هفتگی گروه 2: 5000 واحد بین الملل مکمل ویتامین دی روزانه گروه 3: 1000 واحد بین الملل مکمل ویتامین دی روزانه نمونه های خون قبل و بعد مداخله گرفته می شود. این مطالعه در مشهد-ایران انجام خواهد شد. کورسازی برای بیماران و محققین انجام خواهد شد.
    مداخله در 2 گروه به شرح زیر انجام خواهد شد: گروه 1: 50000 واحد بین الملل مکمل ویتامین دی تک دوز و سپس 10000 واحد بین الملل روزانه گروه 2: 1000 واحد بین الملل مکمل ویتامین دی روزانه نمونه های خون قبل و بعد مداخله گرفته می شود. این مطالعه در مشهد-ایران انجام خواهد شد. کورسازی برای بیماران و محققین انجام خواهد شد.
    The 50000 International Unit (IU) vitamin D supplement weekly, the 5000 IU vitamin D supplement daily and the 1000 IU vitamin D supplement daily
    The 50000 International Unit (IU) vitamin D supplement weekly and then 10000 IU vitamin D supplement daily and the 1000 IU vitamin D supplement daily
    مکمل 50000 واحد بین الملل ویتامین دی هفته ای، مکمل 5000 واحدبین الملل ویتامین دی روزانه، مکمل 1000 واحد بین الملل ویتامین دی روزانه
    مکمل 50000 واحد بین الملل ویتامین دی هفته ای و سپس به صورت روزانه مکمل 10000 واحدبین الملل ویتامین دی ، مکمل 1000 واحد بین الملل ویتامین دی روزانه

  • General information

    210
    140
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    Due to the decrease in the number of study groups, the number of sample sizes for the study was changed to 140 according to the new calculations.
    empty
    به علت کاهش تعداد گروه های مورد مطالعه، تعداد حجم نمونه برای مطالعه با توجه به محاسبات جدید به 140 نفر تغییر کرد.

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Doctor Mohsen Tafaghodi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
    Street address - Persian: میدان آزادی، پردیس دانشگاه علوم پزشکی مشهد، دانشکده پزشکی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177948546
    Phone: +98 51 3800 2420
    Fax:
    Email: Ghayourm@mums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Doctor Mohsen Tafaghodi
    Full name of responsible person - Persian: دکتر محسن تفقدی
    Street address - English: Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
    Street address - Persian: میدان آزادی، پردیس دانشگاه علوم پزشکی مشهد، دانشکده پزشکی
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9177948546
    Phone: +98 51 3841 2081
    Fax:
    Email: tafaghodiM@mums.ac.ir
    Web page address:

Protocol summary

Study aim
Assessment of the effect of vitamin D supplementation among patients with the diagnosis of 2019 Novel Coronavirus infection
Design
Clinical trial containing group control, with parallel groups, double blind, randomized, third phase on 210 patients. Block method will be used for randomization.
Settings and conduct
Interventions in three groups will be performed as below: Group 1: 50000 International Unit (IU) vitamin D supplementation and then 10000 IU supplementation daily Group 2: 1000 IU vitamin D supplementation daily Blood samples will be taken before and after the intervention. This study will be done in Mashhad-Iran. Blinding will be performed for patients and investigators.
Participants/Inclusion and exclusion criteria
Age 30- 60 years old; serum vitamin D level lower than 30 nano gram per milliliter; cases who diagnosed as COVID-19 infection by clinical features; laboratory findings (positive C Reactive Protein, lymphocyte lesser 1100 per milliliter); serum vitamin D level upper than 30 nanogram per milliliter; use of vitamin supplements; use of immune suppressants or medications that interfere with vitamin D metabolism; history of nephrolithiasis; kidney disorders requiring dialysis or current malignancy diagnosis; pregnancy or lactating.
Intervention groups
The 50000 International Unit (IU) vitamin D supplement weekly and then 10000 IU vitamin D supplement daily and the 1000 IU vitamin D supplement daily
Main outcome variables
Chest X-ray findings, CT scan findings, Length of stay, Serum vitamin D level, Serum C-Reactive Protein level, Serum Erythrocyte Sedimentation Rate level, Serum neutrophil to lymphocyte ratio, Fasting Blood Glucose, Low Density Lipoprotein, High Density Lipoprotein, Triglyserid, Total cholesterol

General information

Reason for update
Due to the decrease in the number of study groups, the number of sample sizes for the study was changed to 140 according to the new calculations.
Acronym
IRCT registration information
IRCT registration number: IRCT20110726007117N11
Registration date: 2020-07-05, 1399/04/15
Registration timing: registered_while_recruiting

Last update: 2021-07-06, 1400/04/15
Update count: 1
Registration date
2020-07-05, 1399/04/15
Registrant information
Name
Majid Ghayour Mobarhan
Name of organization / entity
Mashhad University of Medical Sciences,
Country
Iran (Islamic Republic of)
Phone
+98 51 1822 8573
Email address
ghayourm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vitamin D supplementation in diagnosed cases of 2019 Novel Coronavirus; a randomized clinical trial
Public title
Effect of vitamin D supplementation in novel corona virus 2019
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30- 60 years old Serum Vitamin D level lower than 30 nanograms per milliliter Cases who diagnosed as novel coronavirus 2019 infection by clinical features (sore throat, dry cough, dyspnea), laboratory findings (positive C- Reactive protein, lymphocyte<1100 per mililiter), or radiological findings (lung patchy infiltrations in chest X-ray or CT scan)
Exclusion criteria:
Serum Vitamin D level upper than 30 nanograms per milliliter Use of medications that interfere with vitamin D metabolism History of hypercalcemia, kidney disorders, cirrhosis
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants will undergo individual block randomization according to sex status with the use of block size of three. For this randomization, we will use solid blurred envelops containing A or B or C labels.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be perfomed in two levels of patients and investigators (double blind)
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.MUMS.REC.1399.237

Health conditions studied

1

Description of health condition studied
Covid-19 disease
ICD-10 code
U07.1
ICD-10 code description
Use this code when COVID-19 has been confirmed by laboratory testing irrespective of severity of clinical signs or symptoms. Use additional code, if desired, to identify pneumonia or other manifestations.

Primary outcomes

1

Description
C-Reactive Protein level
Timepoint
Measurement of C-Reactive Protein level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
enzyme-linked immunosorbent assay kit

Secondary outcomes

1

Description
Erythrocyte Sedimentation Rate level
Timepoint
Measurement of Erythrocyte sedimentation level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
Westergren method

2

Description
neutrophil to lymphocyte ratio level
Timepoint
Measurement of neutrophil to lymphocyte ratio level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
microscopic count

3

Description
Serum vitamin D level
Timepoint
Measurement of serum vitamin D level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
Enzyme-linked immunosorbent assay

4

Description
Low Density Lipoprotein Level
Timepoint
Measurement of Low Density Lipoprotein level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
Direct detergent method

5

Description
High Density Lipoprotein Level
Timepoint
Measurement of High Density Lipoprotein level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
Direct detergent method

6

Description
Total cholesterol level
Timepoint
Measurement of total cholesterol level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
Direct detergent method

7

Description
Triglyceride level
Timepoint
Measurement of tryglyserid level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
Direct detergent method

8

Description
Fasting Blood Glucose level
Timepoint
Measurement of Fasting Blood Glucose level before starting intervention and 30 days after starting the intake of vitamin D supplementation
Method of measurement
Enzymatic colorimetric method

Intervention groups

1

Description
Intervention group: 50000 International Unit (IU) pearl vitamin D as single dose, made in ZAHRAVI manufacture and then 10000 IU vitamin D syrup , 30 days, with lunch, Made in the department of Pharmacology Mashhad University of Medical Sciences
Category
Treatment - Drugs

2

Description
Control group: 1000 International Unit (IU) syrup vitamin D daily, 30 days, with lunch, Made in the department of Pharmacology Mashhad University of Medical Sciences
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
ِDoctor Majid Ghayour Mobarhan
Street address
Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3800 2420
Email
Ghayourm@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mohsen Tafaghodi
Street address
Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3841 2081
Email
tafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Majid Ghayour Mobarhan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3800 2420
Email
Ghayourm@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Majid Ghayour Mobarhan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3800 2420
Email
Ghayourm@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Khorasanchi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Medicine, Mashhad University of Medical Sciences Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948546
Phone
+98 51 3800 2420
Email
Khorasanchiz981@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
All patients' identical information will be confidential and were not published anywhere.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The study protocol will be published and available to researchers after the study is completed. Statistical analysis and clinical reports of individuals will be available to researchers in the form of articles resulting from the project.
When the data will become available and for how long
Initial access to protocols and articles from 1400
To whom data/document is available
Academic and scientific researchers could apply.
Under which criteria data/document could be used
Scientific articles can be used by researchers.
From where data/document is obtainable
To receive the articles, contact the following e-mail address: Ghayourm@mums.ac.ir
What processes are involved for a request to access data/document
If articles and protocols are published, they can be emailed.
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