History
# Registration date Revision Id
2 2023-11-23, 1402/09/02 286246
1 2023-11-22, 1402/09/01 286003
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  • Protocol summary

    Evaluation of effect of vitamin c on recurrent urinary tract infection in children
    Evaluation of effect of vitamin C on recurrent urinary tract infection in children
    مطالعه حاضر کارآزمایی بالینی با گروه کنترل، با گروه های موازی ، تصادفی سازی شده(با استفاده از تصادفی سازی بلوکی)، فاز 3 بر روی 120بیمار می باشد.
    مطالعه حاضر کارآزمایی بالینی با گروه کنترل، با گروه های موازی، تصادفی سازی شده (با استفاده از تصادفی سازی بلوکی)، فاز 3 بر روی 120بیمار می باشد.
    در این کار آزمایی بالینی تصادفی سازی ، کودکان مبتلا به عفونت ادراری که با علایم عفونت ادراری و کشت ادراری مثبت به بیمارستان امیرکبیر اراک مراجعه کرده اند به وسیله تصادفی سازی بلوکی به دو گروه یکسان مداخله و کنترل تقسیم بندی خواهند شد. در گروه مداخله به مدت یک ماه به کودکان در کنار درمان کلاسیک عفونت ادراری، ویتامینC با دوز250 میلی گرم جویدنی بصورت روزانه داده می‌شود. در حالی که در گروه کنترل فقط درمان کلاسیک عفونت ادراری را دریافت میکنند. در نهایت دو گروه از نظر پیامد های مطالعه مورد ارزیابی قرار خواهند گرفت.
    در این کار آزمایی بالینی تصادفی سازی، کودکان مبتلا به عفونت ادراری که با علایم عفونت ادراری و کشت ادراری مثبت به بیمارستان امیرکبیر اراک مراجعه کرده اند به وسیله تصادفی سازی بلوکی به دو گروه یکسان مداخله و کنترل تقسیم بندی خواهند شد. در گروه مداخله به مدت یک ماه به کودکان در کنار درمان کلاسیک عفونت ادراری، ویتامینC با دوز 250 میلی گرم جویدنی بصورت روزانه داده می‌شود. در حالی که در گروه کنترل فقط درمان کلاسیک عفونت ادراری را دریافت میکنند. در نهایت دو گروه از نظر پیامد های مطالعه مورد ارزیابی قرار خواهند گرفت.
  • General information

    شرکت کنندگان به ترتیب ورود و بر اساس توالی تصادفی سازی که از قبل تولید خواهد شد به دو گروه مداخله و کنترل تخصیص می یابند که این توالی غیر قابل پیش بینی بوده و چیدمان آن کاملا تصادفی است. برای تخصيص نمونه ها از روش تصادفي سازی بلوکی با بلوک های ۸ تایی استفاده خواهد شد . بدین ترتیب ، با استفاده از سایت www.sealedenvelope.com بلوک های 8 تایی از حروف A و B بر اساس حجم نمونه به صورت تصادفی تولید می شود. ترتیب قرار گیری حروف A,B در هر بلوک از بلوک اول تا آخرین بلوک به عنوان توالی تصادفی سازی در نظر گرفته می شود. تولید این بلوک ها و توالی تصادفی آنها تماما توسط این سایت انجام گرفته و محقق از نحوه توالی آنها اطلاعی ندارد.
    شرکت کنندگان به ترتیب ورود و بر اساس توالی تصادفی سازی که از قبل تولید خواهد شد به دو گروه مداخله و کنترل تخصیص می یابند که این توالی غیر قابل پیش بینی بوده و چیدمان آن کاملا تصادفی است. برای تخصيص نمونه ها از روش تصادفي سازی بلوکی با بلوک های ۸ تایی استفاده خواهد شد . بدین ترتیب، با استفاده از سایت www.sealedenvelope.com بلوک های 8 تایی از حروف A و B بر اساس حجم نمونه به صورت تصادفی تولید می شود. ترتیب قرار گیری حروف A,B در هر بلوک از بلوک اول تا آخرین بلوک به عنوان توالی تصادفی سازی در نظر گرفته می شود. تولید این بلوک ها و توالی تصادفی آنها تماما توسط این سایت انجام گرفته و محقق از نحوه توالی آنها اطلاعی ندارد.
  • Primary outcomes

    #1
    urine culture
    Urine culture
  • Intervention groups

    #1
    Intervention group: For one month, in addition to the classical treatment of urinary infection, vitamin C from Osveh Pharmaceutical Company is given in a dose of 250 mg chewable daily.
    Intervention group: For one month, in addition to the classical treatment of urinary infection, vitamin C from Hakiman Teb Kar Pharmaceutical Company is given in a dose of 250 mg chewable daily.
    گروه مداخله: به مدت یک ماه در کنار درمان کلاسیک عفونت ادراری، ویتامینC شرکت داروسازی اسوه با دوز250 میلی گرم جویدنی بصورت روزانه داده می‌شود.
    گروه مداخله: به مدت یک ماه در کنار درمان کلاسیک عفونت ادراری، ویتامین C شرکت داروسازی حکیمان طب کار با دوز 250 میلی گرم جویدنی بصورت روزانه داده می‌شود.
  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Manijeh Kohbazi
    Full name of responsible person - Persian: دکتر منیژه کهبازی
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
    Street address - Persian: اراک ، بیمارستان امیرکبیر ، معاونت آموزشی بیمارستان
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3819691187
    Phone: +98 86 3222 2003
    Mobile: +98 918 161 4351
    Fax: +98 86 3222 2003
    Email: m_kahbazi77@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Manijeh Kohbazi
    Full name of responsible person - Persian: دکتر منیژه کهبازی
    Position - English: Associate professor
    Position - Persian: استادیار
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
    Street address - Persian: اراک، بیمارستان امیرکبیر، معاونت آموزشی بیمارستان
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3819691187
    Phone: +98 86 3222 2003
    Mobile: +98 918 161 4351
    Fax: +98 86 3222 2003
    Email: m_kahbazi77@yahoo.com
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Parsa Yousefi Chaijan
    Full name of responsible person - Persian: دکتر پارسا یوسفی چایجان
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
    Street address - Persian: اراک ، بیمارستان امیرکبیر ، معاونت آموزشی بیمارستان
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3819691187
    Phone: +98 86 3222 2003
    Mobile: +98 911 135 7114
    Fax: +98 86 3222 2003
    Email: parsayousefichaijan@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Parsa Yousefi Chaijan
    Full name of responsible person - Persian: دکتر پارسا یوسفی چایجان
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
    Street address - Persian: اراک، بیمارستان امیرکبیر، معاونت آموزشی بیمارستان
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3819691187
    Phone: +98 86 3222 2003
    Mobile: +98 911 135 7114
    Fax: +98 86 3222 2003
    Email: parsayousefichaijan@yahoo.com
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mitra Shahrjerdi
    Full name of responsible person - Persian: میترا شهرجردی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
    Street address - Persian: اراک ، بیمارستان امیرکبیر ، معاونت آموزشی بیمارستان
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3819691187
    Phone: +98 86 3222 2003
    Mobile: +98 918 630 3394
    Fax: +98 86 3222 2003
    Email: srjdmitra@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mitra Shahrjerdi
    Full name of responsible person - Persian: میترا شهرجردی
    Position - English: Student
    Position - Persian: دانشجو
    Latest degree: a_level
    Area of specialty/work: 30
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
    Street address - Persian: اراک، بیمارستان امیرکبیر، معاونت آموزشی بیمارستان
    City - English: Arak
    City - Persian: اراک
    Province: Markazi
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 3819691187
    Phone: +98 86 3222 2003
    Mobile: +98 918 630 3394
    Fax: +98 86 3222 2003
    Email: srjdmitra@gmail.com
    Web page address:
  • Sharing plan

    محققین دانشگاهی و اساتید دانشگاه پس از برقراری تماس به صورت پیام یا ایمیل با استاد مربوطه می‌توانند درخواست بهره گیری و استفاده از داده ها از دکتر منیژه کهبازی داشته باشد. دکتر منیژه کهبازی: تلفن 09181614351 ایمیل: m_kahbazi77@yahoo.com آدرس: اراک ، بیمارستان امیرکبیر، معاونت آموزشی بیمارستان
    محققین دانشگاهی و اساتید دانشگاه پس از برقراری تماس به صورت پیام یا ایمیل با استاد مربوطه می‌توانند درخواست بهره گیری و استفاده از داده ها از دکتر منیژه کهبازی داشته باشد. دکتر منیژه کهبازی: تلفن 09181614351 ایمیل: m_kahbazi77@yahoo.com آدرس: اراک، بیمارستان امیرکبیر، معاونت آموزشی بیمارستان

Protocol summary

Study aim
Evaluation of effect of vitamin C on recurrent urinary tract infection in children
Design
The present study is a clinical trial with a control group, with parallel groups, randomized (using block randomization), phase 3 on 120 patients.
Settings and conduct
In this randomization clinical trial, children with urinary infection who have referred to Amirkabir Arak Hospital with symptoms of urinary infection and positive urine culture will be divided into two equal intervention and control groups by means of block randomization. In the intervention group, children were given 250 mg of chewable vitamin C daily in addition to the classical treatment of urinary tract infection for one month. While in the control group, they only receive the classical treatment of urinary infection. Finally, two groups will be evaluated in terms of study results.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children with urinary tract infections who have been referred to Amirkabir Arak Hospital with symptoms of urinary tract infection and their infection has been proven by urine culture; Age 2-18 years; The presence of the same urine germs in the urine culture Exclusion criteria: history of constipation; recent use of vitamin C; history of kidney stones; Prohibition of vitamin C consumption in the patient
Intervention groups
In the intervention group, along with the classical treatment of urinary infection, vitamin C with a dose of 250 mg chewable is given daily for one month. In the control group, only the classical treatment will be received, and after one month, a urine culture will be taken.
Main outcome variables
The result of urine culture

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045328N19
Registration date: 2023-11-22, 1402/09/01
Registration timing: prospective

Last update: 2023-11-25, 1402/09/04
Update count: 1
Registration date
2023-11-22, 1402/09/01
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-29, 1402/09/08
Expected recruitment end date
2024-02-27, 1402/12/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of vitamin c on recurrent urinary tract infection in children
Public title
The effect of vitamin C on the recurrence of urinary tract infection in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with urinary infection who have referred to Amirkabir Arak hospital with symptoms of urinary infection and their infection has been proven by urine culture. Age 2-18 years The presence of the same microorganism in urine culture
Exclusion criteria:
History of constipation Recent use of vitamin C History of kidney stones Prohibition of vitamin C consumption in patients
Age
From 2 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The participants will be assigned to two intervention and control groups 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
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.ARAKMU.REC.1402.060

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
Urine culture
Timepoint
One month after the intervention
Method of measurement
Urinalysis

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For one month, in addition to the classical treatment of urinary infection, vitamin C from Hakiman Teb Kar Pharmaceutical Company is given in a dose of 250 mg chewable daily.
Category
Treatment - Drugs

2

Description
Control group: only the classical treatment will be received, and after one month, a urine culture will be taken.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Arak Amir Kabir Hospital
Full name of responsible person
Dr. Manijeh Kohbazi
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
m_kahbazi77@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mehdi Salehi
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3532
Fax
+98 86 3417 3532
Email
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. Manijeh Kohbazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
m_kahbazi77@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Parsa Yousefi Chaijan
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
parsayousefichaijan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mitra Shahrjerdi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Vice Chancellor for Education, Amir Kabir Hospital, Arak, Iran
City
Arak
Province
Markazi
Postal code
3819691187
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
srjdmitra@gmail.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
After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.
When the data will become available and for how long
Access will be from 2024/04/20 to 2027/04/20 for 3 years.
To whom data/document is available
University researchers
Under which criteria data/document could be used
Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.
From where data/document is obtainable
Academic researchers and university professors can request the use of data from Dr. Manijeh Kohbazi after contacting the relevant professor by message or email. Dr. Manijeh Kohbazi: Phone: 09181614351 Email: m_kahbazi77@yahoo.com Address: Arak, Amir Kabir Hospital, Hospital Education Vice-Chancellor
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.
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