Objective
Cognitive impairment is a common complication in patients undergoing chronic hemodialysis. The aim of this study is to investigate the effect of CO Q 10 on cognitive impairment in these patients.
Study design:
This study designed as a Randomized Double Blind Placebo – Controlled clinical trial in phase 2-3.
Study population and sample size:
Eighty patients who undergoing chronic hemodialysis in Semnan Kowsar Hospital are enrolled in study.
The main inclusion and exclusion criteria:
Inclusion criteria: Chronic renal disease which need to hemodialysis.
Exclusion criteria: Have not any exclusion criteria.
Interventions
Patients who fulfilled inclusion criteria will undergo the Mini Mental State Examination (MMSE), then randomly divided into two groups, the intervention group will receive CO Q10, 100 mg daily and control group placebo. Patients in both groups after the 90 days again undergo the Mini Mental State Examination and results of before and after the intervention will be analyzed.
The intervention time
At the beginning of the study and 90 days after administrating of drug or placebo
Outcome of study
Alteration in cognitive status according to the test result.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014103019758N1
Registration date:2014-12-25, 1393/10/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-25, 1393/10/04
Registrant information
Name
Mohamad Reza Tamadon
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7822
Email address
mrt_tamadon@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research and Technology, Semnan University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Coenzyme Q10 effects on cognitive level of hemodialysis patients in Kowsar hospital, Semnan, 2015
Public title
Effects of Coenzyme Q10 on cognitive level of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients who undergoing hemodialysis.
Exclusion criteria: None
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Ethical Committee, Semnan University of Medical Sciences
Street address
Basidj Boulevard
City
Semnan
Postal code
Approval date
2014-12-07, 1393/09/16
Ethics committee reference number
93/534890
Health conditions studied
1
Description of health condition studied
Cognitive state
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder
Primary outcomes
1
Description
Cognitive state
Timepoint
90 Days after intervention
Method of measurement
Interview and standars questionnaire Mini-mental state examination
Secondary outcomes
empty
Intervention groups
1
Description
Patients in case group after mini-mental state examination will receive Coenzym Q10 daily 100 mg, after that mini-mental state examination will be carried out again.
Category
Treatment - Drugs
2
Description
Patients in control group after mini-mental state examination will receive placebo for 90 days and after that mini-mental state examination will be carried out again.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital, Dialysis center
Full name of responsible person
Dr. Shahb Rafati
Street address
Amin Ave., Basidj Boulevard
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
emnan University of Medical Sciences, Vice Chancellor of Research and Technology
Full name of responsible person
Dr. Mohamad Reza Asgari
Street address
Basidj Boulevard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
emnan University of Medical Sciences, Vice Chancellor of Research and Technology
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
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research expert
Other areas of specialty/work
Street address
Amin Ave., Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7822
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medeical Sciences
Full name of responsible person
Dr. Mohamadreza Tamadon
Position
Nephrologist
Other areas of specialty/work
Street address
Amin Ave., Basidj Boulavard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7822
Fax
+98 23 3343 7838
Email
mrt_tamadon@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research expert
Other areas of specialty/work
Street address
Amin Ave., Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7822
Fax
+98 23 3343 7838
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)