Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of vitamin E supplementation on lipid profiles in patients with diabetic nephropathy.
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Design
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Randomized, double-blind, placebo-controlled clinical trial, phase 3, 54 patients
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Settings and conduct
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54 patients with diabetic nephropathy of eligible and referred to Shahid Beheshti Clinic, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Patients with diabetic nephropathy with a proteinuria level>0.3 g/24 h, with or without elevation of serum creatinine levels and aged 40 to 85 years will be included in this study. Exclusion criteria: Vitamin E supplementation within 3 months, pregnant women, chronic liver disease.
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Intervention groups
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Patients will be assigned to receive either vitamin E (intervention group: n=27) or placebo (control group: n=27).
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Main outcome variables
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Outcomes: Lipid profiles (primary outcomes), biomarkers of oxidative stress (secondry outcomes) will be quantified at study baseline and end-of-trial.
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:
IRCT201706055623N117
Registration date:
2017-06-11, 1396/03/21
Registration timing:
registered_while_recruiting
Last update:
2019-09-22, 1398/06/31
Update count:
1
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Registration date
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2017-06-11, 1396/03/21
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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
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Expected recruitment start date
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2017-05-18, 1396/02/28
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Expected recruitment end date
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2017-06-18, 1396/03/28
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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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Clinical trial of the effect of vitamin E supplementation compared with the placebo on lipid profiles in patients with diabetic nephropathy
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Public title
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Effect of supplementation in treatment of patients with diabetic nephropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with diabetic nephropathy
Aged 40 to 85 years
Exclusion criteria:
Vitamin E supplementation within 3 months
Pregnant women
Chronic liver disease
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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:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either vitamin E supplement or placebo. Randomization will be done by the use of Stat Trek software.
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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 in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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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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2017-05-17, 1396/02/27
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Ethics committee reference number
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IR.Kaums.REC.1396.25
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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N08.3
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ICD-10 code description
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Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+)
Primary outcomes
1
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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Triglyceride
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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LDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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VLDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
Secondary outcomes
1
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
2
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Description
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Total glutathione
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
3
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Spectrophotometry
4
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Description
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FPG
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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Description
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HbA1c
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Glycomat kit
Intervention groups
1
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Description
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Intervention group: Vitamin E capsule, 800 mg (Zahravi, Tabriz, Iran), once a day, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
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Category
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Treatment - Drugs
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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Vice chancellor for research, 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