This is a double blind placebo-controlled clinical trial to evaluate the effect of vitamin C on CRP and phosphorus levels in hemodialysis patients.
60 hemodialysis patients who meet inclusion criteria and don’t have exclusion criteria randomly divided into two equal groups.
1- Intervention group who receive vial vit C 500mg/5cc intravenously.
2- Control group who receive 5cc normal saline intravenously.
Each group receives its regimen at the end of hemodialysis 3 times a week for a period of 8 weeks.
After this time period 10cc fasting venous blood sample will be taken from the patients before hemodialysis in order to compare CRP, phosphorus, calcium, oxalate, albumin, cholesterol, hemoglobin, hematocrit and parathyroid hormone levels to its level at the beginning of the study
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904224365N1
Registration date:2010-06-22, 1389/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-22, 1389/04/01
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-08-22, 1389/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous vitamin C on the level of CRP in Hemodialysis patients
Public title
Effect of intravenous vitamin C on the level of CRP and phosphorus in Hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent, being under hemodialysis at least for 6 months prior to the study, being under hemodialysis 3 times a week, age between 20&70 years old
Exclusion criteria: refusal at any time to continue the study, history of Infectious diseases and hospitalization within 2 months prior to the trial, history of vit E, vit C, alcohol & oil fish consumption within 2 months prior to the trial, History of renal transplantation, history of immunosuppressive drugs consumption within 2 months prior to the trial, history of statins and aspirin use, history of liver disease or malignancy, getting Systemic disease during the study
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
sari
Postal code
46175866
Approval date
2010-07-07, 1389/04/16
Ethics committee reference number
89-54
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
serum CRP
Timepoint
before intervention, two months after the intervention
Method of measurement
mg/l-laboratory kit
Secondary outcomes
1
Description
hemoglobin
Timepoint
before intervention, two months after the intervention
Method of measurement
mg/dl , Laboratory kit
2
Description
cholesterol
Timepoint
before intervention, two months after the intervention
Method of measurement
mg/dl , Laboratory kit
3
Description
Phosphorus
Timepoint
before intervention, two months after the intervention
Method of measurement
mgr/dl ,Laboratory kit
Intervention groups
1
Description
Intervention group receives vial vit C 500mg/5cc intravenously at the end of hemodialysis 3 times a week for a period of 8 weeks
Category
Treatment - Drugs
2
Description
Control group receives 5cc normal saline intravenously at the end of hemodialysis 3 times a week for a period of 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
hemodialysis center of Imam Khomeini general Hospital
Full name of responsible person
Afshin Gholipour Baradari, MD- CCMF- Assistant Professor
Street address
hemodialysis center of Imam Khomeini general Hospital- amir st
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Amir Emami Zeidi
Position
MSc of Critical care nursing-Nurse of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 15132612458
Fax
+98 15 1326 2679
Email
amie_ei@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Fatemeh Espahbodi MD
Position
Nefrologist- Assistant Professor
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 15132612458
Fax
+98 15 1326 2679
Email
ftespahbodi@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)