The effect of vitamin E (E) in the prevention of acute kidney injury in leukemia patients receiving vincristine is investigated.
Design
Clinical trial with control group, with parallel group, without blinding, randomized, phase 3 on 36 patients, block randomization method with 4 blocks was used for randomization.
Settings and conduct
It is a randomized clinical trial study with a control group that will be conducted in 1402 at Amirkabir Hospital in Arak city on 36 patients with leukemia treated with vincristine. In this study, after randomization, 18 patients in the control group will receive only routine treatment with vincristine. Meanwhile, 18 patients in the intervention group take 400 units of vitamin E orally daily in addition to routine treatment with vincristine for one month. Blinding was not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 3 to 18 years, - leukemia patients taking vincristine. Exclusion criteria: suffering from chronic kidney disease, allergy to vitamin E medicine
Intervention groups
In the control group, 18 patients will only receive routine treatment with vincristine for one month and will not receive any similar drug with vitamin E.
In the intervention group, 18 patients, in addition to routine treatment with vincristine, will receive one vitamin E gelatin capsule, 400 units (Dana Pharmaceuticals-Iran) for one month.
Main outcome variables
Glomerular filtration rate (GFR)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190717044255N7
Registration date:2023-02-25, 1401/12/06
Registration timing:prospective
Last update:2023-02-25, 1401/12/06
Update count:0
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Ali Azizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3276 7500
Email address
a.azizi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-25, 1402/01/05
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin E on the prevention of acute renal injury in patients with leukemia receiving vincristine
Public title
effect of vitamin E on the prevention of acute renal injury in patients with leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Leukemia patients taking vincristine
Age 3 to 18 years
Exclusion criteria:
Suffering from chronic kidney disease
Allergy to vitamin E medicine
Age
From 3 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are placed in one of the intervention and control groups by random block allocation method with blocks of four. By assigning the letter A to the intervention group and the letter B to the control group, six states AABB, BBAA, BABA, ABBA, BAAB and ABAB are written on separate sheets and thrown into a container and randomly one of the sheets is taken out of the container and the composition written on it is noted and that sheet is thrown into the container again. Because the sample size in this study is 36 patients, this procedure is repeated 9 times and each time the combination written on each sheet is noted in the sequence of the order written on the previous sheet. Then, a number from 1 to 36 is assigned to each of the letters in the order of the letters noted one after the other, and each of the letters is placed in an envelope and the number of that letter is written on the envelope. Every time a disease is selected, one of the envelopes is opened according to the number written on the envelope and it is determined that the patient should be in the intervention or control group.
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
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2022-09-11, 1401/06/20
Ethics committee reference number
IR.ARAKMU.REC.1401.200
Health conditions studied
1
Description of health condition studied
Leukemia
ICD-10 code
C91
ICD-10 code description
Lymphoid leukemia
Primary outcomes
1
Description
Glomerular filtration rate (GFR)
Timepoint
At entry into the study, 48 hours later, one week and one month after the start of treatment
Method of measurement
Creatinine clearance formula
Secondary outcomes
1
Description
Serum creatinine level
Timepoint
At entry into the study, 48 hours later, one week and one month after the start of treatment
Method of measurement
Laboratory measurement of serum creatinine level
Intervention groups
1
Description
Control group: In the control group, 18 patients received routine treatment with vincristine (Richter-Hungary) every week intravenously at a dose of 0.05 mg/kg for one month. During this period, patients will not receive any supplemental medicine containing vitamin E. Also, placebo medicine will not be used in this group.
Category
Treatment - Drugs
2
Description
Intervention group: In the intervention group, 18 patients with leukemia receive routine treatment with vincristine (Richter-Hungary) intravenously at a dose of 0.05 mg/kg every week. In addition, patients in the intervention group will receive one oral gelatin capsule of vitamin E, four hundred units (400 IU) (Dana Pharmaceuticals-Iran) for one month.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Alireza Toghra
Street address
Amirkabir hospital, Parastar sq., Shahid Shiroudi st.
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
Mahdi Salehi
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
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
Alireza Toghra
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098863134905
Email
Dralirezatoghra7273@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Toghra
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098863134905
Email
Dralirezatoghra7273@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Toghra
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Payambar azam complex, Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3819693345
Phone
0098863134905
Email
Dralirezatoghra7273@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available