the purpose of this study is to evaluate the effect of ascorbic acid in the prevention of contrast induced nephropathy.
in This study is involved in a clinical trial on 90 Diabetic patients in which coronary catheterization has taken. The patients were divided randomly into two groups: control group and treatment group. Treatment group given the vitamin C received a 2gram loading dose 2 hours before the intervention and control group was given 2 grams of the Placebo. The Glomerular filtration rate ,Blood Urea Nitrogen,Creatinin was measured before and was compared with each other after 2-3 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013012712293N1
Registration date:2013-05-17, 1392/02/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-17, 1392/02/27
Registrant information
Name
Roya Daryacheey
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1724 0172
Email address
drnough@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi University of Medical Science
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-06-18, 1391/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ascorbic Acid Effect in Prevention of Controst Induce Nephropathy in Diabetic patients
Public title
Effect of Ascorbic Acid in Prevention of Controst Induce nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All diabetic patients who are candidates for cardiac catheterization.
Exclusion criteria: 1- patients whit contrast dye used during the last 5 days;
2- Patients who used vitamin C during the last week;
3- Patients who have received N-Acetyl Cysteine (NAC), dopamine, mannitol and theophylline.
Age
From 59 years old to 77 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
yazd shahid sadughy university of medical science
Street address
yazd.bahonar square
City
yazd
Postal code
8917945556
Approval date
2013-03-06, 1391/12/16
Ethics committee reference number
17/1/180770/پ
Health conditions studied
1
Description of health condition studied
DIABETES MELITUS
ICD-10 code
E10.2
ICD-10 code description
insulin-dependent diabetes melitus with renal complications
2
Description of health condition studied
DIABETES MELITUS
ICD-10 code
E11.2
ICD-10 code description
non-insulin-dependent diabetes melitus with renal complications
Primary outcomes
1
Description
BUN;
Timepoint
before and three days after intervention
Method of measurement
by hematology analysis and mg/dl
2
Description
reatinine
Timepoint
before and 2-3 days after intervention
Method of measurement
by hemathology analysis and mg/dl
Secondary outcomes
empty
Intervention groups
1
Description
case group used 2gr oral VITC before catheterizaation and was measured BUN;Cr;GFR;before and 2-3 days after catheterization.
Category
Treatment - Drugs
2
Description
control group taked 2gr placebo before catheterisation and measured BUN,Cr,GFR before and 2-3 days after catheterisation
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
afshar hospital
Full name of responsible person
dr.roya daryacheey
Street address
yazd_afshar hospital
City
yazd
2
Recruitment center
Name of recruitment center
seiiedoshohada hospital
Full name of responsible person
dr.roya daryacheey
Street address
yazd_emam khomeini street
City
yazd
3
Recruitment center
Name of recruitment center
shahid sadughy hospital
Full name of responsible person
dr.roya daryacheey
Street address
yazd_safaeie
City
yazd
4
Recruitment center
Name of recruitment center
afshar hospital
Full name of responsible person
Dr.Daryacheie
Street address
Yazd,gomhury avenue
City
yazd
5
Recruitment center
Name of recruitment center
shahid sadughi hospital
Full name of responsible person
Dr.Daryacheie
Street address
yazd,safaeieh
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadughy University Medical Sience
Full name of responsible person
dr.leila hadiani
Street address
yazd,bahonar square
City
yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadughy University Medical Sience
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
Shahid Sadooghi University of Medical Sciences, Yazd, Iran
Full name of responsible person
dr.leila hadiani
Position
general medicine
Other areas of specialty/work
Street address
yazd.gomhury avenue.afshar hospital
City
yazd
Postal code
8917945556
Phone
+98 35 1525 5011
Fax
+98 52 53335
Email
drhadiani@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences, Yazd, Iran
Full name of responsible person
dr.leila hadiani
Position
general medicine
Other areas of specialty/work
Street address
yazd,gomhury avenue,afshar hospital
City
yazd
Postal code
8917945556
Phone
+98 35 1525 5011
Fax
+98 52 53335
Email
drhadiani@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadooghi University of Medical Sciences, Yazd, Iran
Full name of responsible person
dr.leila hadiani
Position
general medicine
Other areas of specialty/work
Street address
yazd.gomhury avenue.afshar hospital
City
yazd
Postal code
8917945556
Phone
+98 35 1525 5011
Fax
+98 52 53335
Email
drhadiani@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)