Objectives: The main goal of this study is evaluation of anti-inflammatory effects of coenzyme Q10 (CoQ10) in hemodialysis patients.
Design: This study is a randomized single blind (the researchers who measure the serum concentration of interleukins and analyze results have no information about the group assignment of the patients) clinical trial. One hundred thirty hemodialysis patients will be recruited from 2 dialysis centers.
Setting and conduct: Patients will be assigned to the intervention or control group using the simple blocked randomization. Duration of the study is 3 months.
Participants: Patients undergoing regular hemodialysis for at least 3 months will be entered to the study. Patients with active infection and who are consuming anti-inflammatory drugs or warfarin will be excluded.
Intervention: Patients will receive CoQ10 capsules at dose of 100 mg daily in the intervention group. In the control group patients will only receive their routine drugs.
Main outcome measures: Primary outcome variables: Serum concentration of interleukin 6 and interleukin 33
Secondary outcome variable: Adverse effects
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061722637N2
Registration date:2017-05-21, 1396/02/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-21, 1396/02/31
Registrant information
Name
Naemeh Nikvarz
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5017
Email address
nnikvarz@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Kerman University of Medical Sciences
Expected recruitment start date
2017-02-25, 1395/12/07
Expected recruitment end date
2017-08-25, 1396/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Coenzyme Q10 on the serum concentration of interleukin 6 and interleukin 33 in hemodialysis patients
Public title
Evaluation of the effects of Coenzyme Q10 on the serum concentration of interleukin 6 and interleukin 33 in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who are undergoing regular hemodialysis for at least 3 months will be entered.
Exclusion criteria: Being in active infection phase, having autoimmune diseases, consuming immunosuppressive medications or warfarin, pregnancy, breast feeding
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Office of Vice chancellor for research, Ebn-e-sina Street
City
Kerman
Postal code
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.KMU.REC.1395.862
Health conditions studied
1
Description of health condition studied
End Stage Renal Disease (Hemodialysis)
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5 Chronic uraemia End stage kidney disease: in allograft failure NOS on dialysis without dialysis or transplant
Primary outcomes
1
Description
Serum concentration of interleukin 6
Timepoint
At baseline and at the end of the study
Method of measurement
ELISA kit
2
Description
Serum concentration of interleukin 33
Timepoint
At baseline and at the end of the study
Method of measurement
ELISA kit
Secondary outcomes
1
Description
Adverse effects
Timepoint
During the study
Method of measurement
Patients' report
Intervention groups
1
Description
Intervention 1: CoQ10 100 mg oral capsules, Dosage: 100 mg once daily, Duration: Three months
Category
Treatment - Drugs
2
Description
Intervention 2 (control group): No treatment, Duration: Three months
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Naemeh Nikvarz
Street address
Shafa Hospital, Kowsar Boulevard
City
Kerman
2
Recruitment center
Name of recruitment center
Javad-ol Aemeh Dialysis Center
Full name of responsible person
Naemeh Nikvarz
Street address
25th Alley, North Aboozar Street
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Office of Vice chancellor for research, Ebn-e-sina Street
City
Kerman
Grant name
Grant code / Reference number
95000191
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Zahra Sharifi Negad
Position
Pharmacy student
Other areas of specialty/work
Street address
Faculty of pharmacy, Haft-Bagh Road
City
Kerman
Postal code
7616911319
Phone
+98 34 3132 5000
Fax
+98 34 3132 5003
Email
zahrasharifi12@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Shafa Hospital, Kowsar Boulevard
City
Kerman
Postal code
7618751151
Phone
+98 34 3121 7243
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Naemeh Nikvarz
Position
Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Shafa Hospital, Kowsar Boulevard
City
Kerman
Postal code
7618751151
Phone
+98 34 3121 7243
Fax
+98 34 3132 5003
Email
nnikvarz@kmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)