Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of fish oil supplementation on levels of gene expression related with glycemic control and inflammatory factors in patients with polycystic ovary syndrome.
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Design
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Study design: Parallel double-blind (both patients and researchers) clinical trial. Randomization will be done by the use of computer-generated random numbers.
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Settings and conduct
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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 and Kosar affiliated to Arak University of Medical Sciences, Arak, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years. Exclusion criteria: Pregnant women, diabetes and impaired glucose tolerance, hypo or hyperthyroidism, androgen-secreting tumor, or hyperprolactinemia.
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Intervention groups
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Patients will be assigned to receive either fish oil (n=20) or placebo (n=20). Fish oil and placebos capsules are similar in shape and size.
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Main outcome variables
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Outcomes: Levels of gene expression related with glycemic control (primary outcomes) and inflammatory factors will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Unfortunately, due to carelessness, update request was done after publishing paper. In addition, the requested issues are in accordance with the approved proposal or with the coordination of Vice Chancellor of Research of University.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201609305623N89
Registration date:
2016-10-01, 1395/07/10
Registration timing:
retrospective
Last update:
2019-10-18, 1398/07/26
Update count:
1
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Registration date
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2016-10-01, 1395/07/10
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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 of research, Bushehr University of
Medical Sciences
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Expected recruitment start date
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2016-09-24, 1395/07/03
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Expected recruitment end date
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2016-10-01, 1395/07/10
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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 fish oil 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
Diabetes and impaired glucose tolerance
Hypo or hyperthyroidism
Androgen-secreting tumor
Hyperprolactinemia
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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:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline, after balanced blocked randomisation, subjects will be allocated into two groups to take supplements (n=20) or placebo (n=20). Randomization will be done by the use of computer-generated random 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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Participants, investigators or the assessors of the outcomes are unaware of the study groups.
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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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2016-09-24, 1395/07/03
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Ethics committee reference number
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IR.BPUMS.REC.1395.86
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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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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GLUT-1
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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
Secondary outcomes
1
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Description
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Interleukin 8
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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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Tumor necrosis factor alpha
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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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Interleukin 1
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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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LDLR
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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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Lp(a)
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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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TGF-β
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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
Intervention groups
1
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Description
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Intervention group: 1000 mg fish oil (Barij Essence, Kashan, Iran), twice 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), twice 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 of research, Bushehr University of Medical Sciences
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Proportion provided by this source
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100
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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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available