Protocol summary

Study aim
Determining the effect of omega-3 on the improvement of urinary infection symptoms
Design
The present study is a clinical trial with a control group, with parallel groups, randomized (using block randomization), phase 3 on 100 patients.
Settings and conduct
In this double-blind randomization clinical trial, children with a definite diagnosis of urinary tract infection referred to Amirkabir Arak Hospital will be divided into two identical omega-3 groups by block randomization. In this study, the participants (by placebo pills) and the outcome assessor (by patient coding) will be blinded. In each group, drug treatment will be prescribed daily for 10 days. Finally, two groups will be evaluated in terms of study results.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: children aged 4-18 years with urinary tract infection; Consent to participate in the study Exclusion Criteria: existence of underlying kidney and liver disease; Sensitivity to omega-3
Intervention groups
Omega-3 group: In addition to receiving standard treatment (antibiotic suitable for symptoms, age and gender), children will receive mercury-free Omega-3 capsules produced by Zahrawi company for 10 days. Control group: In this group, children will receive only the standard treatment for 10 days.
Main outcome variables
Fever, Dysuria, frequency, abdominal pain, urinary incontinence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045328N22
Registration date: 2024-05-21, 1403/03/01
Registration timing: registered_while_recruiting

Last update: 2024-05-21, 1403/03/01
Update count: 0
Registration date
2024-05-21, 1403/03/01
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
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of Omega 3 on UTI (Cystitis and pyelonephritis) Symptoms
Public title
effect of Omega 3 on UTI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 4-18 years old with urinary tract infection Consent to participate in the study
Exclusion criteria:
The presence of underlying kidney and liver disease Sensitivity to omega-3
Age
From 4 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 100
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)
Double blinded
Blinding description
This study is double blind. In this way, the intervention group will receive omega-3 along with routine treatment for urinary infection, while the placebo group will receive a similar placebo instead of omega-3. Therefore, the participants do not know the type of medicine received. On the other hand, prescribing the drugs is the responsibility of the supervisor, and the student, who evaluates the information, does not know about the grouping.
Placebo
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
2023-12-31, 1402/10/10
Ethics committee reference number
IR.ARAKMU.REC.1402.200

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
Fever
Timepoint
The beginning and end of treatment
Method of measurement
Mercury Therommeter

2

Description
Dysuria
Timepoint
The beginning and end of treatment
Method of measurement
Take a history

3

Description
Frequency
Timepoint
The beginning and end of treatment
Method of measurement
Take a history

4

Description
abdominal pain
Timepoint
The beginning and end of treatment
Method of measurement
Take a history

5

Description
urinary incontinence
Timepoint
The beginning and end of treatment
Method of measurement
Take a history

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to receiving standard treatment (antibiotic suitable for symptoms, age and gender), children will receive mercury-free Omega-3 capsules produced by Zahrawi company for 10 days.
Category
Treatment - Drugs

2

Description
Control group: In this group, children will receive only the standard treatment for 10 days.
Category
Treatment - Drugs

Recruitment centers

1

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

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Arshia Toghra
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
Email
a.toghra@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
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 2024/09/20 to 2027/09/20 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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