Protocol summary
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Study aim
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The effects of fish oil supplementation on hormonal profiles and oxidative stress parameters in patients with polycystic ovary syndrome
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Design
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In this research, 60 patients with polycystic ovary syndrome who are eligible will be selected. Participants are randomly divided into two groups of intervention and control by computer software.
The design of the study is parallel blind randomized clinical trial.
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Settings and conduct
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60 patients with polycystic ovary syndrome who are eligible and are referred to women sections of Naghavii hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran will be selected.
The design of the study is a double blind randomized clinical tria. Blinding is carried out for patients and researchers and randomization is done by random table numbers.
Patients will be assigned to receive either fish oil (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12 week intervention
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Women with polycystic ovary syndrome aged 18 to 35 years, on the basis of Rotterdam criteria and without smoking abuse will be included in this study.
Exclusion Criteria: Patients who do not want to cooperate؛ patients with polycystic ovary syndrome with revealed diabetes, hypo or hyperthyroidism, hyperprolactinemia are excluded from this study.
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Intervention groups
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Patients will be assigned to receive either fish oil (intervention group: n=30) or placebo (control group: n=30).
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Main outcome variables
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serum levels of total testosterone, Free testosterone, DHEA sulfate, SHBG, oxidative stress factors such as malondialdehyde (MDA), glutathione (GSH), total antioxidant capacity will be measured.
General information
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Reason for update
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The updating process was done after publishing the paper to correct the registration information.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20150606022562N4
Registration date:
2018-02-17, 1396/11/28
Registration timing:
retrospective
Last update:
2023-04-22, 1402/02/02
Update count:
1
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Registration date
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2018-02-17, 1396/11/28
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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, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-12-01, 1396/09/10
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Expected recruitment end date
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2017-12-31, 1396/10/10
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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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The effects of fish oil supplementation on hormonal profiles and oxidative stress parameters in patients with polycystic ovary syndrome
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Public title
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The effect of fish oil in patients 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:
Women aged 18-35
Polycystic ovary syndrome on the basis of Rotterdam criteria
No smoking
Exclusion criteria:
Revealed diabetes
Hypothyroidism or hyperthyroidism
Hyperprolactinemia
Cushing's syndrome and adrenal and ovarian tumors
Unwillingness to continue cooperation
No regular use of the prescribed supplement
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Age
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From 18 years old to 35 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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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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The method of randomization is that women with PCOS are based on two criteria:
BMI (25BMI <and 25BMI≥) and age (30 and 30 ≤) in the stratification
they take. The method of randomization with a simple method and the use of random numbers generated by computer software will be performed.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, participants, researchers, data collectors, evaluators and data analyzers are not aware of which group of placebo and supplemented fish oil 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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2017-10-19, 1396/07/27
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1396.25
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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Total Testosterone
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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ELISA kit
2
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Description
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SHBG
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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ELISA kit
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 12 weeks after intervention
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Method of measurement
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Elisa kit
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 12 weeks after intervention
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Method of measurement
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Calculated with suggested formula
5
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Description
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Insulin sensitivity
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Calculated with suggested formula
Secondary outcomes
1
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Description
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Total Gluthatione
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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In plasma sample will assessed by cholorimetric method. µmol/L
2
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Description
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plasma total antioxidant
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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In plasma sample will assessed by cholorimetric method. µmol/L
3
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Description
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Malondialdehyde (MAD)
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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In plasma sample will assessed by cholorimetric method. µmol/L
4
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Description
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High-sensitivity C-reactive protein
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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Elisa kit
5
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and 12 weeks after intervention
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Method of measurement
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In plasma sample will assessed by cholorimetric method. µmol/L
6
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Description
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Beck score
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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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Questionnaire
7
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Description
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GHQ score
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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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Questionnaire
8
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Description
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DASS-28 score
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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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Questionnaire
9
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Description
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Modified Ferriman Gallwey
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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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Questionnaire
10
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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
11
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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
12
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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
13
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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
14
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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
15
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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
Intervention groups
1
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Description
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Intervention: received two capsules of 1gr fish oil daily for 12 weeks
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Category
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Treatment - Other
2
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Description
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control: received two capsules of placebo daily for 12 weeks
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Category
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Placebo
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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Kashan 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