In this study,in the period of three monthes 80patients with diabetic nephropaty that have inclusion citeria will be compared. Inclusion criteria including: all patients with diabetic nephropathy who have macroalbominuria(proteinuria more than 300 mg/24h);more than 18 years old ; HbA1c less than 12%.Exclusion criteria including: patient who reject usage of determinate dose of studding druge.In case groap 24 houres before study proteiuria ,Urea, Cr,lipid profil measured,then patient whit WWW.Randomiz.Org randomtically divided into Case and Control groaps.Cases treated whit thiamine 300mg /day for three monthes and after three mothes changes in 24 houres proteinuria studied .Then conclusions compared whit control groap who recive standard druge in this period of time.Also B.S ,lipid profile and kidney function testes measured befor and after of treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105302858N3
Registration date:2011-07-08, 1390/04/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-08, 1390/04/17
Registrant information
Name
Hamid Taieby Khosroshahy
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
khosroshahyh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz Univercity Of Medical Sciences and Health Services
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey of thiamin efficacy on proteinuria in diabetic nephropathy
Public title
Survey of thiamin efficacy on urine protein level in diabetic patients with kidney involvement
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria including: all patients with diabetic nephropathy who have macroalbominuria(proteinuria more than 300 mg/24h);more than 18 years old ; HbA1c less than 12%.Exclusion criteria including: patient who reject usage of determinate dose of studding druge.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University Of Medical Siences and Health Services
Street address
Tabriz University Of Medical Siences and Health ServicesGolgasht Ave .Tabiz East Azaraijan Iran,Islamic Republic Of
City
Tabiz
Postal code
Approval date
2011-01-12, 1389/10/22
Ethics committee reference number
8417/4/5
Health conditions studied
1
Description of health condition studied
Proteihuria in diabetic nephropathy
ICD-10 code
E10-E14+
ICD-10 code description
Glomerular disorders in diabetes mellitus
Primary outcomes
1
Description
Changes in urine protein level
Timepoint
Three months after intervention
Method of measurement
Measurment of urine protein level
Secondary outcomes
1
Description
Serum HbA1C Level
Timepoint
Three monthes after intervention
Method of measurement
Plasma level measurment
2
Description
Lipd profil,HbA1C level
Timepoint
Three monthes after intervention
Method of measurement
Measurment of them in plasma
Intervention groups
1
Description
In control groap we use the standard treatment
Category
Treatment - Drugs
2
Description
For cases300mg/day Thiamin for three monthes and for controles standard treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran,Islamic Republic Of ,Tabriz Imam Reza Hospital
Full name of responsible person
Dr.Negar Sheikhdavodi Rezident Of Internal Medicine
Street address
Imam Reza Hospital, Golgasht Ave,Tabiz
City
Tabiz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University Of Medical Siences and Health Services
Full name of responsible person
Miss Maghami
Street address
Tabriz University Of Medical Siences ,Golgasht Ave ,Tabiz
City
Tabriz
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 Siences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Siences and Health Services
Full name of responsible person
Dr.Negar Sheikhdavodi
Position
Rezident Of Internal Medicine
Other areas of specialty/work
Street address
Tabriz University Of Medical Siences and Health ServicesGolgasht Ave .Tabiz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
Soroushm@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Siences and Health Services
Full name of responsible person
Dr.Hamid Taieby Khosroshahyh
Position
Associate Professor Of Nephrology
Other areas of specialty/work
Street address
Tabriz University Of Medical Siences and Health ServicesGolgasht Ave .Tabiz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
Khosroshahyh@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Siences and Health Services
Full name of responsible person
Dr.Negar Sheikhdavodi
Position
Rezident Of Internal Medicine
Other areas of specialty/work
Street address
Tabriz University Of Medical Siences and Health Services Golgasht Ave .Tabiz
City
Tabriz
Postal code
Phone
+98 41 1334 1317
Fax
+98 41 1334 1317
Email
Soroushm@tbzmed.ac.ir
Web page address
WWW.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)