Evaluation the effect of oral N-acetylcysteine on quantitative serum high sensitivity CRP and hemoglobin in end stage renal disease patients under hemodialysis
The aim of this study is to evaluate the effect of N-acetylcysteine on quantitative serum high sensitivity CRP and hemoglobin in end stage renal disease patients under emodialysis who referred to Imam Khomeini hospital and Boo-Ali hospital, Ardabil, Iran. Total of 40 patients with positive CRP who were dialyzed at least three times per week for three months were selected and divided in two intervention and control groups randomly. Patients with chronic inflammatory diseases such as rheumatoid arthritis and lupus, patients who take HRT drugs during menopause, patients with malignant blood diseases such as myelodysplastic syndrome, lymphoma, leukemia, bone marrow aplasia and patients with HIV were excluded from the study. Ferritin,Albumin, Hct , Hgb and Hs CRP were checked before and after intervention for all patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111030821N1
Registration date:2017-03-16, 1395/12/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-16, 1395/12/26
Registrant information
Name
Roya Alaei
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1552 3386
Email address
r.alaei@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ardabil University of Medical Sciences
Expected recruitment start date
2016-10-20, 1395/07/29
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of oral N-acetylcysteine on quantitative serum high sensitivity CRP and hemoglobin in end stage renal disease patients under hemodialysis
Public title
The effect of oral N-acetylcysteine on quantitative serum high sensitivity CRP and hemoglobin in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with positive CRP who were dialyzed at least three times per week for three months
Exclusion criteria: Patients with chronic inflammatory diseases such as rheumatoid arthritis and lupus, patients who take HRT drugs during menopause ,patients with malignant blood diseases such as myelodysplastic syndrome, lymphoma, leukemia, bone marrow aplasia and patients with HIV
Age
From 18 years old to 80 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
40
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 of Ardabil University of Medical Sciences
Street address
Daneshgah st. Ardabil University of Medical Sciences
City
Ardabil
Postal code
56189-85991
Approval date
2016-08-19, 1395/05/29
Ethics committee reference number
IR.ARUMS.REC1395-53
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N 18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
CRP
Timepoint
Before the intervention and one month after intervention
Method of measurement
ELIZA
Secondary outcomes
1
Description
Hemoglobin
Timepoint
Before the intervention and one month after intervention
Method of measurement
CBC
Intervention groups
1
Description
Intervention group: N-acetylcysteine tab, 600 mg bid for 1 month period
Category
Treatment - Drugs
2
Description
Control group: placebo tab bid, for 1 month period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Roya Alaei
Street address
Daneshgah St. Ardabil University of Medical Sciences
City
Ardabil
2
Recruitment center
Name of recruitment center
Boo-Ali Hospital
Full name of responsible person
Roya Alaei
Street address
Daneshgah St. Ardabil University of Medical Sciences
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ardabil University of Medical Sciences
Full name of responsible person
Afshan Sharghi
Street address
Daneshgah St.Ardabil University of Medical Sciences
City
Ardabil
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 Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Roya Alaei
Position
Internal Medicine resident
Other areas of specialty/work
Street address
Daneshgah St. Ardabil University of Medical Sciences
City
Ardabil
Postal code
56189-85991
Phone
+98 45 3352 2248
Fax
Email
r.alaei@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Bahman Bashardoust
Position
Assistant professor in Internal Medicine
Other areas of specialty/work
Street address
Ataei St. Imam Khomeini hospital
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
B_bashardoust@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Roya Alaei
Position
Internal medicine resident
Other areas of specialty/work
Street address
Daneshgah St. Ardabil University of Medical Sciences
City
Ardabil
Postal code
56189-85991
Phone
+98 45 3352 2249
Fax
Email
r.alaei@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)