Protocol summary
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Study aim
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The aim of this study is to determine the effects of vitamin E supplements on advanced glycation end products, oxidative stress and inflammatory markers in diabetic nephropathy patients .
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial
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Settings and conduct
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Patients with diabetic nephropathy eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with diabetic nephropathy, aged 40 to 85 years with a proteinuria level of> 0.3 g / 24 h, with or without serum creatinine level. The exclusion criteria will be the consumption of vitamin E supplements within 3 months, patients with uncontrolled diabetes, pregnant women, and those with liver or inflammatory diseases.
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Intervention groups
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The volunteers divided into two groups 30 patients. one group received per day of vitamin E 1200 IU and another group received placebo capsulles per day for 3 months.
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Main outcome variables
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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
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2014122020374N1
Registration date:
2015-05-06, 1394/02/16
Registration timing:
registered_while_recruiting
Last update:
2019-09-24, 1398/07/02
Update count:
1
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Registration date
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2015-05-06, 1394/02/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research,Kashan University of Medical Sciences and Health Services
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Expected recruitment start date
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2015-03-05, 1393/12/14
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Expected recruitment end date
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2015-05-25, 1394/03/04
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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A survey of effect of vitamin E supplement on advanced glycation end products, oxidative stress and inflammatory markers in diabetic nephropathy patients
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Public title
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The effect of vitamin E on nephropathy complications of diabetic patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patient with diabetic nephropathy
Aged 40 to 85 years
Proteinuria level > 0.3 g/24 h with or without circulating levels of serum creatinine.
Exclusion criteria:
The consumption of vitamin E supplements within 3 months
Patients with uncontrolled diabetes,
Pregnant women
Those with liver or inflammatory diseases
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Age
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From 40 years old to 85 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either vitamin E supplements (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequence
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-03-04, 1393/12/13
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Ethics committee reference number
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29/5/1/5981 /پ
Health conditions studied
1
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Description of health condition studied
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diabetic nephropathy
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ICD-10 code
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E11.2
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ICD-10 code description
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non-insulin-dependent diabetic melitus with renal complications
Primary outcomes
1
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Description
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Tumour necrosis factor-alpha (TNF-alpha)
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Timepoint
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Before and three months after intervention
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Method of measurement
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In serum sample will assessed.by an enzyme-linking immunosorbent assay (ELISA) kit. pg/ml
2
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Description
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Matrix metalloproteinases 9(MMP9)
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Timepoint
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Before and three months after intervention
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Method of measurement
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In serum sample will assessed by ELISA kit. ng/ml
3
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Description
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matix metalloproteinas 2(MMP2)
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Timepoint
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Before and three months after intervention
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Method of measurement
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In serum sample will assessed .by ELISA kit. ng/ml
Secondary outcomes
1
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Description
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advanced glycation end products (AGEs)
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Timepoint
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Before and three months after intervention
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Method of measurement
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In serum sample will assessed .By fluorescence method
2
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Description
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Vitamin E
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Timepoint
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Before and three months after intervention
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Method of measurement
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Enzymatic kits
3
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Description
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Creatinine
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Timepoint
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Before and three months after intervention
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Method of measurement
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Enzymatic kits
4
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Description
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Blood urea nitrogen
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Timepoint
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Before and three months after intervention
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Method of measurement
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Enzymatic kits
5
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Description
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Total protein
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Timepoint
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Before and three months after intervention
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Method of measurement
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Enzymatic kits
6
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Description
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Fasting plasma glucose
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Timepoint
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Before and three months after intervention
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Method of measurement
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Enzymatic kits
7
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Description
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Insulin
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Timepoint
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Before and three months after intervention
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Method of measurement
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ELISA kits
8
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Description
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Malondialdehyde
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Timepoint
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Before and three months after intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Insulin resistance
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Timepoint
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Before and three months after intervention
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Method of measurement
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Calculation using HOMA formula
Intervention groups
1
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Description
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Intervention:daily received 1200 IU vitamin E for three months
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Category
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Treatment - Drugs
2
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Description
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control: daily received placebo for three months
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available