The effect of vitamin E in the treatment of children with acute kidney injury is investigated.
Design
The clinical trial has a control and intervention group without blinding, randomized, phase 2 on 96 patients. the block randomization method was used.
Settings and conduct
In this clinical trial, patients with acute kidney failure referring to Amirkabir Arak Hospital are randomly divided into two intervention and control groups. Both groups are under routine AKI treatment. In the intervention group, in addition to routine treatment, they will receive vitamin E supplement drops daily for ten days. while the control group receives only routine treatment. For both intervention and control groups, creatinine and GFR will be checked upon entering the study, 48 hours later, when they are discharged. The obtained results are recorded in the checklist prepared for this purpose.
Participants/Inclusion and exclusion criteria
1. People with acute kidney failure between the ages of 1 and 13 admitted to Amirkabir Hospital
2. Have the necessary cooperation in following up the treatment
3. Completing the informed consent form.
Exit conditions:
1. Intolerance of vitamin E consumption in the intervention group
2. Unwillingness to continue participating in the study
Intervention groups
n the intervention group of patients, in addition to the routine treatment with fluid therapy, daily according to age, according to the following order (the standard daily consumption amount according to the drug brochure) of vitamin E drops from "Behsa" company, each milliliter of which contains 10 international units of vitamin E. will receive for 10 days.
Main outcome variables
Assessment of acute kidney injury with baseline serum creatinine level is done at the beginning of the study, 48 hours later and at the time of discharge.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231119060103N1
Registration date:2023-11-24, 1402/09/03
Registration timing:registered_while_recruiting
Last update:2023-11-24, 1402/09/03
Update count:0
Registration date
2023-11-24, 1402/09/03
Registrant information
Name
Roya Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3383 8309
Email address
royaaasadi9877@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-12, 1402/08/21
Expected recruitment end date
2024-07-11, 1403/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin E therapy on children with acute kidney injury
Public title
Evaluation of the effect of vitamin E therapy on children with acute kidney injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. People with acute kidney injury between the ages of 1 and 13 admitted to Amirkabir Hospital
2. Have the necessary cooperation in following up the treatment
3. Completing the informed consent form.
Exclusion criteria:
People who do not want to participate in the study
Age
From 1 year old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done, for this purpose, the participants will be assigned to two intervention and control groups according to the order of arrival and based on the randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. . Block randomization method with 8 blocks will be used to allocate the samples. In this way, using the site www.sealedenvelope.com, blocks of 8 letters A and B are randomly generated based on the sample size. The order of placement of letters A and B in each block from the first block to the last block is considered as a randomization sequence. The production of these blocks and their random sequence is completely done by this site and the researcher does not know how they are sequenced.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht St., Salamat St., Arak Medical Sciences Dormitory
City
Arak
Province
Markazi
Postal code
6861748149
Approval date
2023-09-30, 1402/07/08
Ethics committee reference number
IR.ARAKMU.REC.1402.165
2
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Sardasht St., Salamat St., Arak Medical Sciences Dormitory
City
Arak
Province
Markazi
Postal code
6861748149
Approval date
2023-11-12, 1402/08/21
Ethics committee reference number
IR.ARAKMU.REC.1402.165
Health conditions studied
1
Description of health condition studied
Acute kidney injury
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified
Primary outcomes
1
Description
The assessment of acute kidney injury is done by measuring the serum creatinine level
Timepoint
Measurement of serum creatinine level at the beginning of the study, 48 hours later and at the time of discharge
Method of measurement
blood sample
Secondary outcomes
empty
Intervention groups
1
Description
intervention group In addition to the routine treatment with fluid therapy, patients are given vitamin E drops from the "Behsa" company, each milliliter of which contains 10 international units of vitamin E, for 10 day will receive. Age 1-3 years: 18 drops of the desired drug, which is equivalent to 0.9 ml. Age 4-8 years: 21 drops of the desired drug, which is equivalent to 1.05 ml. Age 9-13 years: 33 drops of the desired drug, which is equivalent to 1.65 It is milliliters
Category
Treatment - Drugs
2
Description
Control group: The control group will receive only routine treatment which includes fluid therapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr. Ali Arjmand
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
amirkabir-hospital@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Salehi
Street address
Arak University of medical science, Basij square
City
Arak
Province
Markazi
Postal code
8735610954
Phone
+98 86 3417 3532
Email
www.salehi58@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Arjmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
Aliarjmand1@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Arjmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
Aliarjmand1@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Arjmand
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Shiroudi St. - Nurse Square - Amirkabir Arak Hospital
City
Arak
Province
Markazi
Postal code
3819693181
Phone
+98 86 3313 4715
Email
Aliarjmand1@yahoo.com
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 data can potentially be shared after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions, as well as people working in the industry, can apply for them
Under which criteria data/document could be used
There are no other conditions
From where data/document is obtainable
To the main person responsible for the study; Dr. Ali Arjmand can be contacted at Aliarjmand1@yahoo.com
What processes are involved for a request to access data/document
The applicant can contact the person in charge of the study through the email address and get access to the information as soon as possible after the request