Comparing the effect of adding levothyroxine to steroids versus steroids alone on reducing the duration of relapse requiring hospitalization in children with nephrotic syndrome
Comparing the effect of adding levothyroxine to steroids versus steroids alone on reducing the duration of relapse requiring hospitalization in children with nephrotic syndrome
Design
A controlled clinical trial with parallel groups, phase 3, involving 100 patients
Settings and conduct
We screened all consecutive hospitalized children aged 2-12 years with a diagnosis of NS according to the guidelines of the IPNA. To assess the patients, we conducted complete blood counts, kidney and liver function tests, lipid profiles, and routine urine microscopic examinations. Patients were non-randomly assigned to the levothyroxine group or the control group. Both groups received treatment for relapse with prednisolone at a dose of 2 mg/kg/day until complete remission was achieved. Patients in the levothyroxine group were treated with levothyroxine at a dose of 4 to 6 mcg/kg/day.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) Children with NS
2) serum TSH level grater than 5.5 mIU/L
Exclusion criteria:
1) Congenital NS
2) Secondary NS due to other diseases
Intervention groups
The intervention group consists of patients with nephrotic syndrome who receive levothyroxine intervention along with steroids during a relapse.
The contol group consists of patients with nephrotic syndrome who receive only steroid intervention during a relapse.
Main outcome variables
The time interval between the occurrence of relapse (urine dipstick test 3 and more) and the achievement of improvement measured in days (negative urine test for 3 consecutive days).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201112049368N2
Registration date:2024-05-30, 1403/03/10
Registration timing:retrospective
Last update:2024-05-30, 1403/03/10
Update count:0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Amin Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5422 2821
Email address
amin.taheri2731@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-23, 1401/09/02
Expected recruitment end date
2023-11-23, 1402/09/02
Actual recruitment start date
2022-11-22, 1401/09/01
Actual recruitment end date
2023-11-22, 1402/09/01
Trial completion date
2024-05-18, 1403/02/29
Scientific title
Comparing the effect of adding levothyroxine to steroids versus steroids alone on reducing the duration of relapse requiring hospitalization in children with nephrotic syndrome
congenital nephrotic syndrome
Secondary nephrotic syndrome
GFR less than 60 ml/min/1.73 m2
confirmed hypothyroidism before the diagnosis of nephrotic syndrome
Age
From 2 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
82
More than 1 sample in each individual
Number of samples in each individual:
2
hospitalization required relapse
Actual sample size reached:
84
More than 1 sample in each individual
Actual sample size in each individual:
2
hospitalization required relapse
Randomization (investigator's opinion)
Not randomized
Randomization description
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 AJA University of Medical Sciences
Street address
No. 16, Etemad zade Ave., Fatemi Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۱۷۱۸۵۴۱
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.AJAUMS.REC.1401.143
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
relapse duration
Timepoint
during the whole period of study
Method of measurement
Urinary dipstick test.
Secondary outcomes
1
Description
cumulative dose of prednisolon
Timepoint
At the incidence of remission
Method of measurement
recorded medical instructions and nursing report.
2
Description
cumulative dose of albumin
Timepoint
During relapses
Method of measurement
recorded medical instructions and nursing report.
Intervention groups
1
Description
Intervention group: The intervention group will be treated from the time of hospitalization due to recurrence with an oral levothyroxine tablet manufactured by Iran Hormone Company at a dosage of 4 to 6 micrograms per kilogram of body weight, accompanied by an oral prednisolone tablet produced by Aburaihan Company at a dosage of 2 milligrams per kilogram of body weight. This treatment will continue until the urine dipstick test remains negative for three consecutive days.
Category
Treatment - Drugs
2
Description
Control group: Patients in the control group will also be treated from the time of their hospital admission due to a disease relapse. They will receive an oral dose of prednisolone produced by Aburaihan Company at 2 milligrams per kilogram of body weight. This treatment will also continue until the urine dipstick test has been negative for three consecutive days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Amin Taheri
Street address
No. 62, Nosrat Ave., Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 2917
Fax
Email
amin.taheri2731@gmail.com
Web page address
https://chmc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Amin Taheri
Street address
No. 16, Etemad zade Ave., Fatemi Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Email
amin.taheri2731@gmail.com
Web page address
https://www.ajaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Amin Taheri
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
72 Tan Shahid St. - Alley 37 - No. 17
City
Khaf
Province
Razavi Khorasan
Postal code
9561834465
Phone
+98 51 5422 2821
Email
amin.taheri2731@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Javad Saberinejad
Position
Assistant Professor of Pediatrics Department of AJA University of medical sciences
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
No. 16, Etemad zade Ave., Fatemi Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2449
Email
javad.saberynejad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Amin Taheri
Position
Physician
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
72 Tan Shahid St. - Alley 37 - No. 17
City
Khaf
Province
Razavi Khorasan
Postal code
9561834465
Phone
+98 51 5422 2821
Email
amin.taheri2731@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
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All analyzed data during the study will be shareable after the individuals are rendered unidentifiable.
When the data will become available and for how long
The start of the access period will coincide with the publication of the results.
To whom data/document is available
All researchers working in academic and scientific institutions can apply to receive the data.
Under which criteria data/document could be used
There will be no possibility for individuals who have been granted access to the data to publish the analysis or raw data, and a written commitment will be obtained from them before access to the data to not publish the data or the analysis performed on the data.
From where data/document is obtainable
The request for data access can be made by sending an email to Amin Taheri, the responsible person for the public response of the trial, at amin.taheri2731@gmail.com.
What processes are involved for a request to access data/document
The request will be send to the Deputy of Research and Technology of the Army University of Medical Sciences by the responsible person for the public response of the trial, and after approval by the Deputy of Research, the university will provide the requested data to the applicant. The time frame for the request until the receipt of the documents will be one to two months.