Protocol summary

Study aim
Determination of the effect of vitamin D level on the status of clinical symptoms and laboratory and radiological findings and short-term results of patients with COVID-19
Design
This study is performed as a clinical trial with a control group, with parallel, 3-blind, randomized groups (block method with a volume of 4 was used to determine the sequence of allocation) and with a sample size of 100 people in the first phase. First, everyone fills out the checklist. Allocation sequences that are placed in each envelope and placed next to each other in order and patients open an envelope in order and understand their group (group A or B)
Settings and conduct
This study is performed on COVID-19 patients with vitamin D deficiency in the COVID-19 ward of Imam Hossein Shahroud Hospital in two groups of testing and control. Individuals in the testing group undergo a treatment protocol to increase vitamin D, and the control group did not receive any intervention. Then, at the end of the hospitalization court, both groups are evaluated. Each patient knows in which group they are (A or B) but does not know which group receives the intervention.Also, the information collector, information analyst, and laboratory manager do not know which intervention group to receive.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Individual satisfaction to participate in the project, Confirmation of COVID-19 disease by CPR test, Non-entry criteria: Vitamin D levels more than thirty nanograms per millilitre
Intervention groups
Test group: intramuscularly Injections of 300 mg of vitamin D at the beginning of the first week, as well as another dose at the beginning of the second week. Control group: No intervention.
Main outcome variables
Clinical course, paraclinical, in-hospital outcome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200411047024N1
Registration date: 2020-04-29, 1399/02/10
Registration timing: prospective

Last update: 2020-04-29, 1399/02/10
Update count: 0
Registration date
2020-04-29, 1399/02/10
Registrant information
Name
Hossein Sheibani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 2820
Email address
sheybani@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effect of treatment with IM(intramuscular) D3 on clinical, paraclinical symptoms and signs and in-hospital outcome at patient admitted with coovid19
Public title
Evaluation effect of treatment with IM D3 on clinical, paraclinical symptoms and signs and inhospital outcome at patient admitted with coovid19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individual satisfaction to participate in the project Confirmation of covid-19 disease by CPR test
Exclusion criteria:
Vitamin D levels are more than 30 Nanograms /milliliter
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The allotment sequence is determined using the website. Block method 4 was used to determine the allocation sequence. White envelopes are used to hide the allocation sequence. In this way, each sequence is placed inside a white envelope and the envelopes are arranged side by side and we number the letters to don't be disorganized. For each eligible participant, an envelope will be opened and assigned to the desired group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
White envelopes are used to hide the allocation sequence. In this way, each sequence is placed inside a white envelope and the envelopes are arranged side by side, and the patients take one envelope each in order of entering the design, and according to the letter in the envelope (A or B) are divided into two groups, and only the ward nurse knows that which group must receive the intervention, but the person in charge of data collection, the head of the laboratory and information analysis does not know which group received the intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahrud University of Medical Sciences
Street address
Shahrud University of Medical Sciences, 7 Tir Square, Shahrud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Approval date
2020-04-04, 1399/01/16
Ethics committee reference number
IR.SHMU.REC.1399.013

Health conditions studied

1

Description of health condition studied
COIVD-19 patient
ICD-10 code
U07.1
ICD-10 code description
covid-19, virus identified

Primary outcomes

1

Description
Clinical course
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
By recording information about the variables defined from the patients' hospital records

2

Description
Paraclinical
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Registration of patient's laboratory information and CT scan

3

Description
outcome
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Doctor's approval and death certificate

Secondary outcomes

1

Description
Duration of hospitalization
Timepoint
End of hospitalization
Method of measurement
Hospital file

2

Description
Severe chest pain
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Ask the patient

3

Description
Severe shortness of breath
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Ask the patient

4

Description
how many days after hospitalization they died
Timepoint
End of hospitalization
Method of measurement
ask the patient

Intervention groups

1

Description
Intervention group: Intramuscular Injection of 300 milligrams of vitamin D at the beginning of the week, as well as another dose at the beginning of the week.
Category
Treatment - Other

2

Description
Control group: This group are treated by normal treatment process without any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Shahroud Hospital
Full name of responsible person
hossien sheybani
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahroud
City
Shahroud
Province
Semnan
Postal code
۳۶۱۴۷-۷۳۹۴۷
Phone
+98 23 3339 5054
Email
kazemi.e@shmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahroud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
sheybani@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahroud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
kazemi.e@shmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
hossien sheybani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahroud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
shyebani@shmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Erfan Kazemi
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shahroud University of Medical Sciences, 7 Tir Square, Shahroud
City
Shahrud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 5054
Email
kazemi.e@shmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is made available to the public after unidentifiable identification
When the data will become available and for how long
Data access period begins 2 months after the article is published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions or to people working in the industry
Under which criteria data/document could be used
They can do any kind of analysis with data. And the data can be used in any research direction, otherwise it must be coordinated with the researcher.
From where data/document is obtainable
email:erfankazemi305@gmail.com number:0098 9155868605
What processes are involved for a request to access data/document
Applicants can contact us by e-mail or the mentioned number to receive information.
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