Investigation of the effect of using Montelucast on reducing the recurrence of steroid dependence nephrotic syndrome
Design
Clinical trial with control and parallel groups, single blind, simple randomization
Settings and conduct
This study is carried out on children with nephrotic syndrome referring to Dr.Seikh Hospital in Mashhad. Convenience sampling method is used. Patients with nephrotic syndrome who had one-time minor recurrence with 1+ and 2+ Proteinuria, in case of being under 15 years old and acquiring parents' consent for participation, will enter the study. Complications related to Montelucast such as stomachache, gastrointestinal symptoms, mood disorders will be controlled and recorded and cases will be excluded from the study if necessary. Ratio of urine protein to creatinine, Serum Albumin, rate of short term recovery, and complications in all patients will be evaluated before and one month after the beginning of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with frequently relapsing nephrotic syndrome and sensitivity to steroid.
Exclusion criteria: extreme edema, resistance to treatment with Corticosteroid
Intervention groups
Intervention group: One 5-mg Montelucast pill (produced by Adibi-pharma company) is prescribed daily for one month with 1 mg/kg Prednisolone
Control group: Prednisolone (produced by Iran-hormone company) with dosage of 1 mg/kg is prescribed for a month. Maximum daily dosage is 60 mg.
Main outcome variables
ratio of urine protein to creatinine, Serum Albumin, creatinine, Cholesterol, rate of short term recovery, and complications in all patients before and one month after the beginning of the treatment.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111024007892N9
Registration date:2020-04-03, 1399/01/15
Registration timing:registered_while_recruiting
Last update:2020-04-03, 1399/01/15
Update count:0
Registration date
2020-04-03, 1399/01/15
Registrant information
Name
Anoosh Azarfar
Name of organization / entity
Mashhad University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 51 1606 1227
Email address
azarfara@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-09, 1398/07/17
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of using Montelucast on reducing the recurrence of steroid dependence nephrotic syndrome
Public title
Use of Montelucast in reducing the recurrence of steroid dependence nephrotic syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with frequently relapsing nephrotic syndrome ( 4 times or more in a year)
sensitivity to steroid ( proper response to treatment with oral Corticosteroid with dosage of 1-2 mg/kg in a patient)
Exclusion criteria:
extreme edema
resistance to treatment with Corticosteroid
Age
To 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is performed using table of random numbers produced by www.randomization.com website in such a way that numbers are placed in sealed envelopes and each envelope is allocated to one patient assigning them to one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyst will be unaware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-06-18, 1398/03/28
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.511
Health conditions studied
1
Description of health condition studied
frequently relapsing nephrotic syndrome with sensitivity to steroid
ICD-10 code
N04.0
ICD-10 code description
Nephrotic syndrome with minor glomerular abnormality
Primary outcomes
1
Description
ratio of urine protein to creatinine
Timepoint
before and one month after the beginning of treatment
Method of measurement
biochemical test
2
Description
Serum Albumin
Timepoint
before and one month after the beginning of treatment
Method of measurement
biochemical test
3
Description
creatinine
Timepoint
before and one month after the beginning of treatment
Method of measurement
biochemical test
4
Description
Cholesterol
Timepoint
before and one month after the beginning of treatment
Method of measurement
investigation in laboratory
5
Description
short term rate of recovery
Timepoint
one month after the beginning of treatment
Method of measurement
clinical observation
6
Description
complications
Timepoint
one month after the beginning of treatment
Method of measurement
clinical observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One 5-mg Montelucast pill (produced by Abidi-pharma company under Airokast brand name) is prescribed daily for one month with 1 mg/kg Prednisolone
Category
Treatment - Drugs
2
Description
Control group: Prednisolone (produced by Iran-hormone company) with dosage of 1 mg/kg for one month will begin. (maximum dosage of 60 mg per day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Sahar Malaekeh
Street address
Dr. Sheikh Hospital, Tohid Square, Taheri Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
63185- 91399
Phone
+98 51 3726 9021
Email
malaekehns961@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Sahar Malaekeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Dr. Sheikh Hospital, Tohid Square, Taheri Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
63185- 91399
Phone
+98 51 3726 9021
Email
malaekehns961@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Sheikh Hospital, Tohid Square, Taheri Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
63185- 91399
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoosh Azarfar
Position
Associated professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Dr. Sheikh Hospital, Tohid Square, Taheri Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
63185- 91399
Phone
+98 51 3726 9021
Email
azarfara@mums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.