Protocol summary
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Study aim
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Evaluation of effect of vitamin C on recurrent urinary tract infection in children
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Design
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The present study is a clinical trial with a control group, with parallel groups, randomized (using block randomization), phase 3 on 120 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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The result of urine culture
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2023-11-22, 1402/09/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-11-29, 1402/09/08
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Expected recruitment end date
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2024-02-27, 1402/12/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of effect of vitamin c on recurrent urinary tract infection in children
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Public title
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The effect of vitamin C on the recurrence of urinary tract infection in children
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 2 years old to 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
120
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-06-06, 1402/03/16
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Ethics committee reference number
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IR.ARAKMU.REC.1402.060
Health conditions studied
1
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Description of health condition studied
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Urinary tract infection
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ICD-10 code
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N39.0
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ICD-10 code description
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Urinary tract infection, site not specified
Primary outcomes
1
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Description
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Urine culture
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Timepoint
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One month after the intervention
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Method of measurement
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Urinalysis
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: only the classical treatment will be received, and after one month, a urine culture will be taken.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Access will be from 2024/04/20 to 2027/04/20 for 3 years.
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To whom data/document is available
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University researchers
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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Letter writing should be done with professors and universities.
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Comments
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