A survey of effect of vitamin E supplement on advanced glycation end products, oxidative stress and inflammatory markers in diabetic nephropathy patients
This study is randomized controlled trial to evaluate the effects of vitamin E supplements on advanced glycation end products, oxidative stress and inflammatory markers in diabetic nephropathy patients .60 of patients that referred to kidney sections of Beheshti hospital and dialysis center of Akhavan based on inclusion and exclusion criteria for study are invited.The volunteers divided into two groups 30 patients. one group received two capsules per day of vitamin E 400 IU and another group received two placebo capsulles per day for 3 months. Before and after the intervention serum levels of vitamin E, an advanced glycation end products (AGE), inflammatory factors such as matrix metalloproteinase 9 and 2 (MMP9-2) , TNF_alpha , malondialdehyde (MDA) oxidative stress factor , HOMA-IR and proteinuria can be measured
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014122020374N1
Registration date:2015-05-06, 1394/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-05-06, 1394/02/16
Registrant information
Name
Esmat Aghadavod
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
aghadavod@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2015-04-25, 1394/02/05
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of effect of vitamin E supplement on advanced glycation end products, oxidative stress and inflammatory markers in diabetic nephropathy patients
Public title
The effect of vitamin E on nephropathy complications of diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: type 2 diabetic patient with complications nephropathy؛ In women not being pregnant ؛Not smoking and alcohol abuse ؛The lack of specific diseases such as cardiovascular,cancer,inflammatory diseases , autoimmune and hyper or hypo thyroid ؛Not having urinary tract infections and any other diseases that is causing proteinuria ؛ No change in dose glucose-lowering drugs؛ Not taking non-steroidal and steroidal anti-inflammatory drugs, anti-oxidants , drugs that interfere with the activation of matrix metalloproteinase and also the lack of use of antihypertensive drugs , medications containing estrogen and progesterone؛ Non use of anticoagulation
exclusion criteria:
Any failure to comply with the conditions listed in each phase of the study or the patients unwillingness to continue cooperation will result in removal of the patient from study .
Age
From 35 years old to 95 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee kashan university of medical sciences and health services
Street address
kashan university of medical sciences and health services, Ravand road
City
kashan
Postal code
Approval date
2015-03-04, 1393/12/13
Ethics committee reference number
29/5/1/5981 /پ
Health conditions studied
1
Description of health condition studied
diabetic nephropathy
ICD-10 code
E11.2
ICD-10 code description
non-insulin-dependent diabetic melitus with renal complications
Primary outcomes
1
Description
advanced glycation end products (AGEs)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed .By fluorescence method
2
Description
Tumour necrosis factor-alpha (TNF-alpha)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by an enzyme-linking immunosorbent assay (ELISA) kit. pg/ml
3
Description
Matrix metalloproteinases 9(MMP9)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed by ELISA kit. ng/ml
4
Description
Malondialdehyde (MAD)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed.by method of satho.in this method the reaction of MDA with thiobarbituric acid creates a complex which is determined spectrophotometric.µmol/L
5
Description
matix metalloproteinas 2(MMP2)
Timepoint
Before and three months after intervention
Method of measurement
In serum sample will assessed .by ELISA kit. ng/ml
Secondary outcomes
empty
Intervention groups
1
Description
Intervention:
daily received two capsules of 400 mg of vitamin E for three months
Category
Treatment - Drugs
2
Description
control: daily received two capsules of placebo for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kidney Sections of Beheshti Hospital
Full name of responsible person
Dr.Alireza Soleimani
Street address
Beheshti Hospital ,Ravand road
City
kashan
2
Recruitment center
Name of recruitment center
Dialysis Department of Hospital Akhavan
Full name of responsible person
Dr.Alireza Soleimani
Street address
Dialysis Department of Hospital Akhavan , Abazr Street , 15 khordad Square
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr.Gholam Ali Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences ,Ravand road
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Dr.Esmat Aghadavod Jolfaie
Position
PhD Clinical Biochemistry/ Academic staff member of the Department of Clinical Biochemistry
Other areas of specialty/work
Street address
Medical Faculty , Kashan University of Medical Sciences , Ravand road.
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
Aghadavod_m@Yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Esmat Aghadavod
Position
PhD Clinical Biochemistry /Academic staff member of the Department of Clinical Biochemistry
Other areas of specialty/work
Street address
Medicak Faculty,Kashan University of Medical Sciences,Ravand road
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
Aghadavod_m@Yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Esmat Aghadavod Jolfaie
Position
phD Clinical Biochemistry/Academic staff member of the Department of Clinical Biochemistry
Other areas of specialty/work
Street address
Medical Faculty , Kashan University of Medical Sciences, Ravand road
City
Kashan
Postal code
iran
Phone
+98 31 5554 0021
Fax
Email
Aghadavod_m@Yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)