The assessment of oral vitamin E on blood pressure compared to the placebo in patients with chronic renal failure receiving hemodialysis 2024- (A double blind randomized clinical trial)
1) Determining the blood pressure level before and after the intervention (for 8 weeks and once a week) in two studied groups of hemodialysis patients
2) Comparison of blood pressure levels before and after intervention (for 8 weeks and weekly) in each group of hemodialysis patients
3) Comparison of blood pressure level after intervention (for 8 weeks and once a week) between two groups of hemodialysis patients
Design
Interventional, double-blind, randomized, controlled prospective clinical trial
For 2 months on 30 hemodialysis patients aged between 18 and 70 years
Groups receiving vitamin E and placebo
Settings and conduct
Measuring blood pressure in stages, before the intervention, at the end of each week after the intervention and after the intervention
Receiving vitamin E and placebo randomly for 2 months on 30 hemodialysis patients
Blinding of participants, care providers and data analysts
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Hemodialysis Patients
18-70 years old
Shiraz University of Medical Sciences HD center
Maintenance HD for at least 3 months
Exclusion criteria:
Smoking and alcohol consumer
Anti-oxidant supplements use
Liver or Heart Failure
Diabetes mellitus
Obstructive uropathy
Endocrine cancers
Hemoglobine <9 mg/dL
Coronary vessels disease
Intervention groups
The first group will be given one daily vitamin E supplement in the form of capsules with a dose of 400 units per day manufactured by Karen Pharmaceutical Company, and the second group will be given an oral placebo similar to the drug manufactured by Karen Pharmaceutical Company for 8 weeks. Patients are asked to take placebo or vitamin E at home.
Main outcome variables
Blood Pressure (systolic and diastolic)
General information
Reason for update
Acronym
VitE-SNURC
IRCT registration information
IRCT registration number:IRCT20090701002113N3
Registration date:2024-06-30, 1403/04/10
Registration timing:prospective
Last update:2024-06-30, 1403/04/10
Update count:0
Registration date
2024-06-30, 1403/04/10
Registrant information
Name
Jamshid Roozbeh
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 6400
Email address
roozbehj@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-10, 1403/04/20
Expected recruitment end date
2024-10-11, 1403/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of oral vitamin E on blood pressure compared to the placebo in patients with chronic renal failure receiving hemodialysis 2024- (A double blind randomized clinical trial)
Public title
Effect of Vitamin E on Blood Pressure of Hemodialysis Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis Patients
18-70 years old
Shiraz University of Medical Sciences HD center
Maintenance HD at least for 3 months
Exclusion criteria:
Smoking and alcohol consumer
Anti-oxidant supplements use
Liver or Heart Failure
Diabetes mellitus
Obstructive uropathy
Endocrine cancers
Hemoglobine <9 mg/dL
Coronary vessels disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed by an independent statistician using a computerized random number generator through the block randomization method of SAS 9.3 software. Eligible participants will be randomly assigned 1:1 to either a placebo group or treatment group. All subjects eligible for selection/exclusion criteria at visit 2 (baseline visit, week 0) will be assigned to a group according to the allocation codes of the blocked randomization method. Each patient will be given a unique study number. An independent data manager who is not involved with the clinical practice or patient recruitment will create the randomization sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
The care providers, participants, outcome assessors, and statisticians will be kept blinded to treatment allocation throughout the trial. The randomization lists will be computer-generated and concealed from the investigators by an independent data manager not involved in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Khalili Street
City
Shiraz
Province
Fars
Postal code
7193635899
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.SUMS.MED.REC.1402.545
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Blood Pressure (systolic and diastolic)
Timepoint
Before the intervention, the beginning of the intervention (the first day), the end of each week after the intervention and the end of the intervention (the end of the eighth week).