Determination of vitamin D supplementation effect on the recovery of hospitalized children suffering from Coronavirus disease 2019
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 40 patients. Sealed Envelope online software was used for randomization.
Settings and conduct
Children 3 months to 14 years old suffering from Coronavirus disease 2019 admitted to 17 Shahrivar Hospital in Rasht city during 2021 are selected by random sampling method. Patients are randomly divided into two groups by the random block method. An online address (www.sealedenvelope.com) is used to generate a random list. Study groups include intervention group 1: receiving vitamin D at a dose of 1000 IU daily, control group: receiving placebo. To blind the type of intervention, closed and numbered envelopes are used and patients are identified with the same code until the end of the study. The doctor, the evaluator and the patient are blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children suffering from Coronavirus disease 2019, 3 to 14 months old hospitalization children in hospital; Exclusion criteria: Children that have a history of hepatitis disease, children that have malabsorption disorder, children that are undergoing chemotherapy
Intervention groups
The intervention group is hospitalized children suffering from Coronavirus disease 2019 who will receive daily vitamin D with a dose of 1000 international units. The control group is hospitalized children suffering from Coronavirus disease 2019 who will receive a placebo made by Barij Essan company, daily.
Main outcome variables
Time to stop fever, stop respiratory distress and hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090909002438N4
Registration date:2022-10-11, 1401/07/19
Registration timing:registered_while_recruiting
Last update:2022-10-11, 1401/07/19
Update count:0
Registration date
2022-10-11, 1401/07/19
Registrant information
Name
Houman Hashemian
Name of organization / entity
Guilan University of medical sciences- Medical faculty- 17 Shahrivar hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9061
Email address
hashemian@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Vitamin D Supplementation on the Recovery of Hospitalization Children Suffering from Coronavirus Disease 2019 in Hospital
Public title
"Evaluation of the Effect of Vitamin D Supplementation on the Recovery of Children Suffering from Coronavirus Disease 2019"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children suffering from coronavirus disease 2019 (COVID-19)
3 months to 14 years old hospitalization children in hospital
Exclusion criteria:
Children that have a history of hepatitis disease
Children that have malabsorption disorder
Children that are undergoing chemotherapy
Age
From 3 months old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
20
According to the number of cases suffering from Coronavirus disease 2019 in the hospital last year (51 cases) and due to the low prevalence and vaccination of patients in recent years, 20 people in each group are selected. Samples include hospitalized children suffering from Coronavirus disease 2019 in hospitals that have 3 months to 14 years of age.
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is random block allocation, and patients will be randomly divided into two groups, including intervention with vitamin D and the control group with placebo. The randomization unit is individual and people will be selected individually. Randomization will be done in the form of sealed opaque envelopes with a random sequence. At first, each of the randomly generated sequences is recorded on a card. Then, the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the numbered envelopes is placed in the same order. After that, the lid of the envelopes is glued and they are placed in the box in order. The randomization tool is online software (www.sealed envelope.com). First, registration is done on the site. The number of blocks is 5 and 8 people are selected in each block. According to the required sample size and block size, a randomization list of people to be placed in treatment groups is produced. At the time of registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug concealment was also performed using opaque envelopes sealed in random sequence, opaque envelopes, sealed, numbered respectively. Each random sequence created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of the participants, one of the envelopes of the letter is opened in order and the assigned group of that participant is revealed. The coding is done by one of the project partners and the evaluating physician and the patient are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Parastar Ave., Farhang Square., Rasht Town, Iran
City
Rasht
Province
Guilan
Postal code
41937-13111
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.GUMS.REC.1401.116
Health conditions studied
1
Description of health condition studied
Coronavirus Disease 2019
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified
Primary outcomes
1
Description
The effect of vitamin D consumption on the fever
Timepoint
Assess the severity of the Coronavirus disease 2019 at the beginning of the study (before the intervention) and every 24 hours after starting cunsumtion of vitamin D as daily
Method of measurement
Mercury thermometer device
2
Description
The effect of vitamin D consumption on the respiratory distress
Timepoint
Assess the severity of the Coronavirus disease 2019 at the beginning of the study (before the intervention) and every 24 hours after starting consumption of vitamin D as daily
Method of measurement
Pulse oximeter device
3
Description
The effect of vitamin D consumption on hospitalization
Timepoint
Assess the severity of the Coronavirus disease 2019 at the beginning of the study (before the intervention) and every 24 hours after starting consumption of vitamin D as daily
Method of measurement
Number of days of hospitalization for treatment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Hospitalized children with COVID-19 are 3 months to 14 years old and will receive daily vitamin D with a dose of 1000 international units
Category
Treatment - Other
2
Description
Control group: Hospitalized children with COVID-19 are 3 months to 14 years old and will receive a daily Placebo made by Barij Essence Company.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Houman Hashemian
Street address
Parastar Ave., Farhang Square., Rasht Town, Iran
City
Rasht
Province
Guilan
Postal code
13111-41937
Phone
+98 13 3334 6489
Fax
+98 13 3333 3125
Email
hashemian@gums.ac.ir
Web page address
https://isid.research.ac.ir/Houman_Hashemian
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Street address
Parastar Ave., Farhang Square., Rasht Town, Iran
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3334 6489
Fax
+98 13 3333 3125
Email
hashemian@gums.ac.ir
Web page address
https://isid.research.ac.ir/Houman_Hashemian
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Ave., Farhang Square., Rasht Town, Iran
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3334 6489
Fax
+98 13 3333 3125
Email
hashemian@gums.ac.ir
Web page address
https://isid.research.ac.ir/Houman_Hashemian
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Ave., Farhang Square., Rasht Town, Iran
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3334 6489
Fax
+98 13 3333 3125
Email
hashemian@gums.ac.ir
Web page address
https://isid.research.ac.ir/Houman_Hashemian
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Houman Hashemian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Ave., Farhang Square., Rasht Town, Iran
City
Rasht
Province
Guilan
Postal code
41937-13111
Phone
+98 13 3334 6489
Fax
+98 13 3333 3125
Email
hashemian@gums.ac.ir
Web page address
https://isid.research.ac.ir/Houman_Hashemian
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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 documents or patient data files will be provided to the Vice Chancellor for Research and Treatment. The results of the study will be published in the form of an article resulting from the project without mentioning the names of the participants.
When the data will become available and for how long
The access period is 6 months after the publication of results in the form of an article.
To whom data/document is available
The results of the research will be available to all researchers as a published article.
Under which criteria data/document could be used
Researchers will send a written request to executor of the project stating the reasons and details for accessing the data and documentation. After review by the ethics committee and the research council, if approved, will be sent.
From where data/document is obtainable
Researchers will send a written request to executor of the project stating the reasons and details for accessing the data and documentation.
What processes are involved for a request to access data/document
Researchers will send a written request to executor of the project stating the reasons and details for accessing the data and documentation. After review by the ethics committee and the research council, if approved, will be sent.
Comments
The applicant must also state in full detail the reason for his / her need for data and documentation.