This study is a randomized clinical trial that disigned to assess effect of oral N-acetyl cystein in 32 hemodialysis patients referred to Sadoughi and Rahnemoon hospital in yazd. Inclusion critera include: patients undergone hemodialysis that received hemodialysis for more than 3 month with 3 sessions per week. Exclusion criteria include: Patients undergone hemodialysis with venous catheter; symptoms of active infection in one month before starting the study and during the study; rising liver enzymes(ALT and AST); blood transfusion during the study; collagen vascular diseases were the etiology of end stage renal disease; age lesser than 18 –year- old, use of corticosteroid and immunosuppressive drugs; history of myocardial infarction or stroke in 3 month before starting the study; history of intolerance or allergy to NAC. Patients will be given NAC, effervescent tablet 600 miligram twice daily for 2 months.Blood samples will collect at the beginning and end of the study before initiation of dialysis for testing HbA1C, total cholestrol, triglyceride, albumine, calcium, phosphor, Malondialdehyde (MDA) and highly sensitive CRP (hs CRP).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111529812N2
Registration date:2016-12-14, 1395/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-12-14, 1395/09/24
Registrant information
Name
Roya Hemayati
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3724 0171
Email address
drhemayati@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Yazd University of Medical Sciences
Expected recruitment start date
2014-03-16, 1392/12/25
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral N-acetyl cystein on inflammatory markers in hemodialysis patients
Public title
effect of oral NAC in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion critera: patients undergone hemodialysis that received hemodialysis for more than 3 month with 3 sessions per week. Exclusion criteria: Patients undergone hemodialysis with venous catheter; symptoms of active infection in one month before starting the study and during the study; rising liver enzymes(ALT and AST); blood transfusion during the study; collagen vascular diseases were the etiology of end stage renal disease; age lesser than 18 –year- old, use of corticosteroid and immunosuppressive drugs; history of myocardial infarction or stroke in 3 month before starting the study; history of intolerance or allergy to NAC.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of ShahidSadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square, Yazd, Central Organization of Shahid Sadoughi University of Yazd Medical Sciences and Health Services
City
Yazd
Postal code
8916978477
Approval date
2014-03-11, 1392/12/20
Ethics committee reference number
17/1/257428
Health conditions studied
1
Description of health condition studied
Nephropathy
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
Hs-CRP
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
Mg/dl
2
Description
MDA
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
µmol/dl
3
Description
Albomin
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
g/dl
4
Description
Cholesterol
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
Mg/dl
5
Description
Triglycerides
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
Mg/dl
6
Description
Hb-A1C
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
g/dl
7
Description
Calcium
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
Mg/dl
8
Description
Phosphorus
Timepoint
At baseline and Two months after the initiation of trial
Method of measurement
Mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
intervention(NAC, 600 mg, twice daily, for two months)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rahnemoun Hospital-Yazd
Full name of responsible person
Roya Hemayati
Street address
Farokhi Street, Shahid Rahnemoun Hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of University of Medical Sciences and Health Services, Yazd
Full name of responsible person
Mehrparvar Hoshang
Street address
Bahonar Sq, Yazd
City
Yazd
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 of University of Medical Sciences and Health Services, Yazd
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
Nephrology Department, Shahid Sadoughi University of Medical Sciences, Yazd, Iran