Protocol summary
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Study aim
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Assessment of the effect of vitamin D supplementation among patients with the diagnosis of 2019 Novel Coronavirus infection
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Design
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Clinical trial containing group control, with parallel groups, double blind, randomized, third phase on 210 patients. Block method will be used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2020-07-05, 1399/04/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2021-01-20, 1399/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of vitamin D supplementation in diagnosed cases of 2019 Novel Coronavirus; a randomized clinical trial
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Public title
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Effect of vitamin D supplementation in novel corona virus 2019
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
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Sample size
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Target sample size:
140
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blinding will be perfomed in two levels of patients and investigators (double blind)
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-09, 1399/02/20
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Ethics committee reference number
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IR.MUMS.REC.1399.237
Health conditions studied
1
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Description of health condition studied
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Covid-19 disease
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ICD-10 code
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U07.1
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ICD-10 code description
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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
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Description
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C-Reactive Protein level
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Timepoint
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Measurement of C-Reactive Protein level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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enzyme-linked immunosorbent assay kit
Secondary outcomes
1
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Description
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Erythrocyte Sedimentation Rate level
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Timepoint
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Measurement of Erythrocyte sedimentation level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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Westergren method
2
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Description
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neutrophil to lymphocyte ratio level
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Timepoint
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Measurement of neutrophil to lymphocyte ratio level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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microscopic count
3
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Description
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Serum vitamin D level
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Timepoint
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Measurement of serum vitamin D level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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Enzyme-linked immunosorbent assay
4
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Description
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Low Density Lipoprotein Level
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Timepoint
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Measurement of Low Density Lipoprotein level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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Direct detergent method
5
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Description
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High Density Lipoprotein Level
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Timepoint
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Measurement of High Density Lipoprotein level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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Direct detergent method
6
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Description
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Total cholesterol level
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Timepoint
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Measurement of total cholesterol level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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Direct detergent method
7
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Description
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Triglyceride level
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Timepoint
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Measurement of tryglyserid level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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Direct detergent method
8
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Description
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Fasting Blood Glucose level
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Timepoint
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Measurement of Fasting Blood Glucose level before starting intervention and 30 days after starting the intake of vitamin D supplementation
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Method of measurement
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Enzymatic colorimetric method
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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All patients' identical information will be confidential and were not published anywhere.
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Initial access to protocols and articles from 1400
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To whom data/document is available
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Academic and scientific researchers could apply.
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Under which criteria data/document could be used
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Scientific articles can be used by researchers.
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From where data/document is obtainable
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To receive the articles, contact the following e-mail address:
Ghayourm@mums.ac.ir
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What processes are involved for a request to access data/document
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If articles and protocols are published, they can be emailed.
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Comments
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