Determining the effect of vitamin E intake on improving the symptoms of children 2 to 12 years old with urinary tract infections admitted to Ayatollah Mousavi Hospital in 2021-2022
Design
Clinical trial with control group, with parallel, randomized, phase 3 groups on 48 patients
Settings and conduct
This study is performed as a clinical trial for 48 patients aged 2-12 years who will be admitted to the pediatric ward of Ayatollah Mousavi Hospital in Zanjan in 2021-2022 due to urinary tract infection as indicated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Complete consent to participate in the study, all patients 2 to 12 years with a diagnosis of urinary tract infection
Exclusion criteria: emphysematous pyelonephritis, renal abnormalities, vitamin E sensitivity or intolerance
Intervention groups
An intervention group and a control group participated in this study.In the intervention group, in addition to routine treatments, vitamin E capsules will be taken orally dose 100 units daily for 10 days, and in the control group will receive only routine treatments.
Main outcome variables
Improve the symptoms of urinary tract infection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210627051722N1
Registration date:2021-07-14, 1400/04/23
Registration timing:registered_while_recruiting
Last update:2021-07-14, 1400/04/23
Update count:0
Registration date
2021-07-14, 1400/04/23
Registrant information
Name
Malihe naghdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3313 0000
Email address
drmnaghdi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-18, 1399/11/30
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin E intake in improving the symptoms of children 2 to 12 years old with urinary tract infections
Public title
Evaluation of the effect of vitamin E intake in improving the symptoms of children 2 to 12 years old with urinary tract infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
All patients 2 to 12 years with diagnosis of urinary tract infection (urine analysis and positive urine culture)
Exclusion criteria:
Emphysematous pyelonephritis
Renal anomalies
Allergy to vitamin E or intolerance to it
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected from 48 patients aged 2 to 12 years with a diagnosis of urinary tract infection admitted to the pediatric ward in Ayatollah Mousavi Hospital, Zanjan University of Medical Sciences. Individuals are randomly divided into two groups receiving vitamin E and the control group. Random allocation will be considered as Block permutation Randomization with four blocks including AABB-BBAA-BABA-ABAB-BAAB-ABBA and individuals will be assigned to intervention or control groups based on these blocks (which will be randomly selected).
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 Deputy of Research and Technology of Zanjan University of Medical Sciences
Street address
Deputy of Research and Technology, third floor, Second building, Central Headquarters of Zanjan University of Medical Sciences, The beginning of Jomhuri Eslami Boulevard, Azadi Blv, Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-01-25, 1398/11/05
Ethics committee reference number
IR.ZUMS.REC.1398.448
Health conditions studied
1
Description of health condition studied
urinary tract infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
Improve the symptoms of urinary tract infection
Timepoint
On days 4 and 10 of treatment
Method of measurement
Urine culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, in addition to routine treatments, vitamin E capsules are taken orally in 100 units daily for 10 days.
Category
Treatment - Drugs
2
Description
Control group: In the control group will receive only routine treatments.
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
After completing the study, there is a plan to share non-identifiable individual data of the participants, the study protocol, the statistical analysis of the data, the informed consent form patents, clinical reports, analysis codes, and data coding systems (Dictionary).
When the data will become available and for how long
The start of the access period to the data of this study will be from Early 2022 and approximately 6 months after the publication of the results.
To whom data/document is available
The data from this study will be available to all people who can play a role in caring for children with urinary tract infection in 2 to 12 years , such as families, and healthcare workers.
Under which criteria data/document could be used
The researcher tend to use data to improve patients, especially children with urinary tract infection in 2 to 12 years.
From where data/document is obtainable
To receive information anyone can be use the following email:moezi@zums.ac.ir
What processes are involved for a request to access data/document
The data will be sended to the applicants after her introduction and the reason for the need for data