Efficacy of gluten free food diet in decreasing proteinuria in steroid resistant nephrotic syndrome patients
Design
clinical trial without control group, single group, designed of 25 patients, non randomised
Settings and conduct
25 patients of steroid resistant nephrotic syndrome in tabriz emam reza hospital that has given 1-2 mg/kg of prednisolon for at least 2 month and his/her proteinuria has nor decreases at least for 50% will be given gluten free diet for 2 month.
patients will be studied for renal functions, urea, cr, serum albumin, urine analysis, 24 hour urine protein, routine lab and lipid profile before and after diet
steroid resistant nephrotic syndrome patients before and after using gluten free diet , control group patients in this study are patient before using gluten free diet. we select the patients who were on steroid and impressiveness resistant for at least 6 months and resistant to treatment. then these patients to place on gluten free diet for 2 months. the diet is supply by Isuda diet company
Main outcome variables
decreasing proteinuria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200512047415N1
Registration date:2021-05-30, 1400/03/09
Registration timing:retrospective
Last update:2021-05-30, 1400/03/09
Update count:0
Registration date
2021-05-30, 1400/03/09
Registrant information
Name
Hamid Tayyebi Khosroshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3177 1042
Email address
tayebikhosroshahi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2021-01-18, 1399/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of gluten free food diet in tratment of steroid resistant nephrotic syndrome patients
Public title
Efficacy of gluten free food diet
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
steroid resistant nephrotic syndrome patients
patients that incline to participate
Exclusion criteria:
pregnant patients
diabetic nephropathy patients
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Faculty of medicine, next to Imam Reza General Hospital , Across from Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2020-06-29, 1399/04/09
Ethics committee reference number
IR.TBZMED.REC.1399.324
Health conditions studied
1
Description of health condition studied
steroid resistant nephrotic syndrome patients
ICD-10 code
N04
ICD-10 code description
Primary outcomes
1
Description
decreasing in proteinuria before and after 2 month of gluten free diet
Timepoint
before and after 2 month of gluten free diet
Method of measurement
comparing amount of proteinuria before and after 2 month of gluten free diet
Secondary outcomes
empty
Intervention groups
1
Description
25 patients of steroid resistant nephrotic syndrome in tabriz emam reza hospital that has given 1-2 mg/kg of prednisolon for at least 2 month and his/her proteinuria has nor decreases at least for 50% will be given gluten free diet for 2 month. patients will be studied for renal functions, urea, cr, serum albumin, urine analysis, 24 hour urine protein, routine lab and lipid profile before and after diet.The control group are the patients before getting gluten free diet.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz emam reza hospital
Full name of responsible person
heidar hazemi
Street address
Tabriz emam reza hospital, golgasht st, azadi ave
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
tayebikhosroshahi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamid Tayebi khosroshahi
Street address
Imam Reza General Hospital , Across from Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
tayebikhosroshahi@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Heidar Hazemi
Position
resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza General Hospital , Across from Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
dr.hazemi59010@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Heidar Hazemi
Position
resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza General Hospital , Across from Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
dr.hazemi59010@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Heidar Hazemi
Position
resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza General Hospital , Across from Central Building of Tabriz University of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 2073
Email
dr.hazemi59010@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
Yes - There is 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
Demographic information and raw data obtained from experiments
All data are accessible
When the data will become available and for how long
immediately after publishing results
To whom data/document is available
everybody in related fields of study
Under which criteria data/document could be used
everybody in related fields of study with noting the source of data
From where data/document is obtainable
contact this email adress : dr.hazemi59010@gmail.com
What processes are involved for a request to access data/document
If the mentioned access conditions are met, the data will be delivered within 2 weeks after contacting the mentioned email