Protocol summary
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Study aim
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The aim of this study is to determine the effects of Q10 supplementation on levels of gene expression related with glycemic control and inflammatory factors, and metabolic profiles in patients with polycystic ovary syndrome.
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Design
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Parallel double-blind (both patients and researchers) clinical trial
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Settings and conduct
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Among patients with polycystic ovary syndrome referred to Kosar Clinic affiliated to Arak University of Medical Sciences and Persian Gulf Martyrs Hospital affiliated to Bushehr University of Medical Sciences, 60 patients (for metabolic profiles and 40 patients for gene expression) will be selected according to inclusion and exclusion criteria.
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Participants/Inclusion and exclusion criteria
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Patients with polycystic ovary syndrome aged 18 to 40 years will be included in this study. Exclusion criteria will as follows: Pregnant women, adrenal hyperplasia, androgen-secreting tumors, hyperprolactinaemia, thyroid dysfunction, diabetes or impaired glucose tolerance, gastrointestinal problems, no hormonal treatments in the previous 6 months in the study.
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Intervention groups
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Patients will be assigned to receive either Q10 (n=30) or placebo (n=30) for metabolic profiles, and to receive either Q10 (n=20) or placebo (n=20) for gene expression.
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Main outcome variables
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Levels of gene expression related with glycemic control and insulin metabolism (primary outcomes), and gene expression related to inflammatory factors and lipid profiles (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Due to an error, the request for an update in our website has conducted after paper published. However, the revisions were accordance with either the original approved proposal or with coordination with Vice Chancellor of Research at the University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201605225623N80
Registration date:
2016-06-04, 1395/03/15
Registration timing:
retrospective
Last update:
2020-08-26, 1399/06/05
Update count:
1
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Registration date
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2016-06-04, 1395/03/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Arak University of Medical Sciences
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Expected recruitment start date
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2016-04-25, 1395/02/06
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Expected recruitment end date
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2016-05-05, 1395/02/16
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of Q10 supplementation compared with the placebo on levels of gene expression related with glycemic control and inflammatory factors in women with polycystic ovary syndrome
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Public title
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Effect of supplementation in treatment of women with polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with PCOS according to Rotterdam criteria
Aged 18 to 40 years
Exclusion criteria:
Pregnant women
Adrenal hyperplasia
Androgen-secreting tumors
Hyperprolactinaemia
Thyroid dysfunction
Diabetes or impaired glucose tolerance
Gastrointestinal problems
No hormonal treatments in the previous 6 months in the study
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients will be randomly assigned into each intervention group by their numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic who is not involved in the trial and not aware of random sequences will be allocated the numbered bottles of capsules to participants. Supplements and placebo are in the same packaging at the pharmaceutical company. Only the code is written on the packages. Patients and researcher do not know the type of drug and after analyzing the data, packet codes are decoded.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-04-24, 1395/02/05
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Ethics committee reference number
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IR.ARAKMU.REC.1395.35
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Expressed levels of PPAR-γ
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Expressed levels of GLUT1 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
3
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Description
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Serum insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Eliza
4
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation with HOMA formula
Secondary outcomes
1
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Description
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Expressed levels of TNFα gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
2
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Description
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Expressed levels of TGFB gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
3
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Description
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Expressed levels of IL-1 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
4
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Description
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Expressed levels of IL-8 gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
5
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Description
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Expressed levels of LDLR gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
6
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Description
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Expressed levels of Lp(a) gene
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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PCR
7
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Description
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Fasting plasma glucose
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
8
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
9
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Description
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VLDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
10
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
11
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Description
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LDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
12
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
Intervention groups
1
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Description
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Intervention group: 100 mg Q10 (Nature, New York, USA), once a day, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Arak University of Medical Sciences
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Proportion provided by this source
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33
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Vice chancellor of research, Bushehr University of Medical Sciences
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Proportion provided by this source
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33
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
3
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Vice chancellor of research, Kashan University of Medical Sciences
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Proportion provided by this source
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34
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable