Evaluation of vitamin C in contrast induced nephropathy
Design
A randomized, blinded, clinical trial with a parallel group design of 100 patients under angiography between Jun 2017 and November 2017.
Settings and conduct
This study will be done in Mazandaran Heart center and practitioner and analyzer is blind .
Participants/Inclusion and exclusion criteria
End stage renal disease
History of contrast use in past 3 days or 1 week after starting study
Nephrotoxic drug use
Vitamin C use in past 7 days
Intervention groups
In Intervention group, 3 gram before and 2 gram after angiography then 1 gram daily for 5 days will be prescribed. Every patients will take 10 gram vitamin C totally.
In control group, Placebo ( Same shape, odor and appearance) instead of vitamin C will be prescribed.
Main outcome variables
Nephropathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151109024975N7
Registration date:2018-07-05, 1397/04/14
Registration timing:registered_while_recruiting
Last update:2018-07-05, 1397/04/14
Update count:0
Registration date
2018-07-05, 1397/04/14
Registrant information
Name
Gohar Eslami
Name of organization / entity
Mazandaran University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3695
Email address
g.eslami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-20, 1397/03/30
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ascorbic acid in preventing contrast-induced nephropathy in patients undergoing angiography : Double blind Random clinical trial
Public title
Ascorbic acid in contrast-induced nephropathy
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
patients undergoing angiography and contrast media
Contrast nephropathy score above 5
Age between 18-85
Exclusion criteria:
End stage Renal disease patients
Contrast usage 1 week before and 72 hours after study
Coadministration of nephrotoxic drug
Vitamin C usage during last 1 week
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
double blind ( practitioner, Analyzer)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Saadi Ave, farhang St
City
Sari
Province
Mazandaran
Postal code
4818844765
Approval date
2017-03-10, 1395/12/20
Ethics committee reference number
IR.MAZUMS.REC.95.2554
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.0
ICD-10 code description
Acute coronary thrombosis not resulting in myocardial infarction
Primary outcomes
1
Description
Nephropathy
Timepoint
5 days
Method of measurement
creatine
Secondary outcomes
1
Description
نفروپاتی
Timepoint
1 week
Method of measurement
creatine
2
Description
dialysis
Timepoint
10 days
Method of measurement
Creatinin
3
Description
mortality
Timepoint
2 weeks
Method of measurement
patients follow up
Intervention groups
1
Description
Intervention group: 3 grams of oral vitamin C ( Dr Abidi Manufacturing) before angiography and 2 grams afterwards, and then daily for 1 gram during 5 days. Each patient receive 10 grams of ascorbic acid in total.
Category
Treatment - Drugs
2
Description
Control group: 3 grams of Placebo ( Same as vitamin C appearance) before angiography and 2 grams afterwards, and then daily for 1 gram during 5 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh-zahra hospital Mazandaran University of Medical Scienses
Full name of responsible person
Gohar Eslami
Street address
َ Center of the heart of Mazandaran,Artesh Blvd
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3331 4086
Fax
+98 11 3332 4002
Email
Dr.gohar.eslami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical sciences
Full name of responsible person
Research commitee Mazandaran University of Medical sciences
Street address
Moalem Sq, Sari
City
Sari
Province
Mazandaran
Postal code
4818844765
Phone
+98 11 3310 8906
Email
Dr.gohar.eslami@gmail.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
َ Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Saadi, ّFarhang St
City
Sari
Province
Mazandaran
Postal code
4818844765
Phone
+98 331108906
Email
Dr.gohar.eslami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Asistance of professor of clinical pharmacy
Full name of responsible person
Gohar Eslami
Position
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Payambar Azam Complex, 18 Km Farah Abad Blvd, Khazar Square
City
Sari
Province
Mazandaran
Postal code
48188
Phone
+98 11 3354 3082
Fax
Email
G.eslami@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Mazandaran University of Medical Sciences
Full name of responsible person
Gohar Eslami
Position
Asistance of Professor Clinical Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Sari
City
Sari
Province
Mazandaran
Postal code
4818844765
Phone
+98 911 154 1131
Fax
Email
dr.gohar.eslami@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available