Clinical trial of the effect of coenzyme Q10 supplementation compared with the placebo on gene expression related to inflammation and lipid in patients with polycystic ovary syndrome
Objective: The aim of this study is to determine the effects of Q10 supplementation on gene expression related to inflammation and lipid in patients with polycystic ovary syndrome. Study design: Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. Inclusion criteria: Patients with polycystic ovary syndrome and aged 18 to 40 years will be included in this study. Exclusion criteria: Unwillingness to cooperate will be excluded in the study. Population and sample size: 40 patients with polycystic ovary syndrome of eligible and referred to Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, Bushehr, Iran in the study will be selected. Intervention: Patients will be assigned to receive either Q10 (n=20) or placebo (n=20). Q10 and placebos capsules are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and end of the intervention: 12 weeks. Outcomes: Gene expression related to inflammation (primary outcomes) and lipid (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612315623N97
Registration date:2017-01-02, 1395/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2016-11-15, 1395/08/25
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of coenzyme Q10 supplementation compared with the placebo on gene expression related to inflammation and lipid in patients with polycystic ovary syndrome
Public title
Effect of supplementation in treatment of patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with polycystic ovary syndrome; aged 18 to 40 years. Exclusion criteria: Unwillingness to cooperate.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random assignment will be done by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Bahmani Campus, Bushehr University of Medical Sciences, Sabzabad Blvd
City
Bushehr
Postal code
Approval date
2016-11-14, 1395/08/24
Ethics committee reference number
IR.BPUMS.REC.1395.105
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovary syndrome
Primary outcomes
1
Description
TNF-α
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR-RT
2
Description
IL-1
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR-RT
Secondary outcomes
1
Description
Ox-LDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR-RT
Intervention groups
1
Description
Intervention group: 100 mg coenzyme Q10 (Nature, New York, USA), once a day, for 12 weeks orally.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Persian Gulf Martyrs Hospital
Full name of responsible person
Dr Elham Rahmani
Street address
Persian Gulf Martyrs Hospital, Borj square, Borj Blvd
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostovar
Street address
Bahmani Campus, University of Medical Sciences, Sabzabad Blvd
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Bushehr 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
PhD of Nutrition
Other areas of specialty/work
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Postal code
Phone
+98 31 5546 3378
Fax
Email
asemi_z@kaums.ac.ir; asemi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)