Protocol summary

Study aim
Evaluation the Effect of Montelukast as an adjunctive therapy on Nephrotic Syndrome in Children
Design
This assessment is a clinical trial in Phase 3, children diagnosed with nephrotic syndrome that have been verified by pediatric specialist, are considered as study group. In this study, 40 children who meet the criteria are selected. Patients are categorized based on non randomization method, 20 children in the intervention group and 20 children in the control group. Accordingly, at the beginning of the diagnosis and 1 months after the start of treatment, the condition of the nephrotic syndrome is evaluated by signs and symptoms.
Settings and conduct
This study will be done as a clinical trial at the pediatric Clinic of Amir Kabir Hospital in Arak, Also the study will also be single blinded in which patients will be blinded in study.
Participants/Inclusion and exclusion criteria
Inclusion criteria is the only Nephrotic Syndrome, while patients who are not available during the next year to refer to the facility for follow-up or have other underlying conditions (such as hematology diseases or any other chronic disease), or intake drug for another illness, were excluded.
Intervention groups
In intervention group, in addition to the usual treatment of nephrotic syndrome (corticosteroid), we also used vitamin D, in which Montelukast is administered as tables of 5 mg, in addition in control group we used the usual treatment for Nephrotic Syndrome is 60 mg / m2 / day is 60 mg of prednisolone (maximum dose of 80 mg / m2 / day) for 4-6 weeks, which is used in the control group.
Main outcome variables
Albumin level, Urinary tract infection, Edema

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130518013366N13
Registration date: 2020-03-24, 1399/01/05
Registration timing: registered_while_recruiting

Last update: 2020-03-24, 1399/01/05
Update count: 0
Registration date
2020-03-24, 1399/01/05
Registrant information
Name
Parsa Yousefi Chaijan
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1964
Email address
dr.yousefi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-08, 1398/06/17
Expected recruitment end date
2020-09-06, 1399/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Effect of Montelukast as an adjunctive therapy on Treatment results (Proteinuria, Edema, Albumin Level) of Nephrotic Syndrome in Children
Public title
The effect of Montecukast on Nephrotic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Affected to Nephrotic Syndrome
Exclusion criteria:
Underlying blood disease Underlying liver disease
Age
To 15 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
This means that patients in groups do not know the used drugs, and drugs has similar packaging.
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
Arak University of Medical Sciences, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.ARAKMU.REC.1398.228

Health conditions studied

1

Description of health condition studied
Nephrotic Syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome

Primary outcomes

1

Description
Albumin level
Timepoint
Before treatment and 2 months after the administration of Montelukast
Method of measurement
Blood test

2

Description
Urinary tract Infection
Timepoint
Before treatment and 2 months after the administration of Montelukast
Method of measurement
Urine test

3

Description
Edema
Timepoint
Before treatment and 2 months after the administration of Montelukast
Method of measurement
Physical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In these patients, in addition to the usual treatment of nephrotic syndrome including 60 mg / m2 / day is 60 mg of prednisolone (maximum dose of 80 mg / m2 / day) for 4-6 weeks, we also used Montelukast, in which Montelukast as tables of 5 mg administered daily.
Category
Treatment - Drugs

2

Description
Control group: The usual treatment for Nephrotic Syndrome is 60 mg / m2 / day is 60 mg of prednisolone (maximum dose of 80 mg / m2 / day) for 4-6 weeks, which is used in the control group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Pediatrics, Amir Kabir Hospital
Full name of responsible person
Fatemeh Javidi
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
Fatemehjavidi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Arash Anoushirvani
Street address
3819693345, Vice Chancellor for Research, Arak University of Medical Sciences, Sardasht, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
arashanoushirvani@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
Fatemeh javidi
Position
Pediatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatric
Street address
3819693345, Amir Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
Fatemehjavidi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefichaijan
Position
Associate Professor of Pediatric Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
3819693345, Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
parsayousefichaijan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parsa Yousefichaijan
Position
Associate Professor of Pediatric Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
3819693345, Amir-Kabir Hospital, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 5075
Email
parsayousefichaijan@yahoo.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
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