The prophylactic effect of co-enzyme Q10 versus placebo on contrast-induced nephropathy in patients with diabetes mellitus type II: a double-blind randomized clinical trial study
To assess the prophylactic effect of coenzyme Q10 versus placebo on contrast-induced nephropathy in patients with diabetes mellitus type II
Design
This is a double-blind randomized clinical trial, phase II, in which 104 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients with diabetes mellitus type II referring to the Shahid Beheshti Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded so that neither patients nor the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Diabetes mellitus type II for at least one year,
Need for CT scan with contrast material,
Microalbuminuria or macroalbuminuria
Exclusion criteria:
Pregnancy or breastfeeding,
Receiving contrast material last week,
Taking antioxidants last week,
Kidney activity instability,
Sensitivity to iodinated contrast agents
Intervention groups
Intervention group:
Coenzyme Q10 100 mg capsule (manufactured by Hakiman Teb Pharmaceutical Company) daily one day before angiography until 6 days after
Control group:
Placebo capsule (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) daily one day before angiography until 6 days after
Main outcome variables
Primary outcome:
Serum creatinine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N337
Registration date:2020-01-29, 1398/11/09
Registration timing:prospective
Last update:2020-01-29, 1398/11/09
Update count:0
Registration date
2020-01-29, 1398/11/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The prophylactic effect of co-enzyme Q10 versus placebo on contrast-induced nephropathy in patients with diabetes mellitus type II: a double-blind randomized clinical trial study
Public title
The prophylactic effect of co-enzyme Q10 versus placebo on contrast-induced nephropathy in patients with diabetes mellitus type II
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Diabetes mellitus type II for at least one year,
Need for CT scan with contrast material,
Microalbuminuria or macroalbuminuria
Exclusion criteria:
Pregnancy or breastfeeding,
Receiving contrast material last week,
Taking antioxidants last week,
Kidney activity instability,
Sensitivity to iodinated contrast agents
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be given in coded envelops. The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.UMSHA.REC.1398.875
Health conditions studied
1
Description of health condition studied
Diabetes mellitus with nephropathy
ICD-10 code
E08.21
ICD-10 code description
Diabetes mellitus due to underlying condition with diabetic nephropathy
Primary outcomes
1
Description
Serum creatinine
Timepoint
Daily before the intervention and 7 days after that
Method of measurement
By laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Coenzyme Q10 100 mg capsule (manufactured by Hakiman Teb Pharmaceutical Company) daily one day before angiography until 6 days after
Category
Treatment - Drugs
2
Description
Control group: Placebo capsule (manufactured by the laboratory of School of Pharmacy, Hamadan University of Medical Sciences) daily one day before angiography until 6 days after
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan city
Full name of responsible person
Ashkan Karbasi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
akarbasi@gmx.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ashkan Karbasi
Position
PhD Student of Biochemistry
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
akarbasi@gmx.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Heidar Tayebnia
Position
Biochemist
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
tayebinia@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available