Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of omega-3 plus vitamin E 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 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: Among patients with PCOS referred to Kosar Clinic affiliated to Arak University of Medical Sciences, 40 patients will be selected according to inclusion and exclusion criteria.
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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: Smoking, intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months, intake of anti-inflammatory or antidiabetic drugs, pregnancy, other causes of hyperandrogenism and/or anovulation.
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Intervention groups
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Intervention group: Combined 1000 mg omega-3 fatty acids and 400 IU vitamin E, manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
Control group: Placebo manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered orally.
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Main outcome variables
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Outcomes: Parameters of mental health (primary outcomes), levels of gene expression related with glycemic control and inflammatory factors (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:
IRCT201605215623N79
Registration date:
2016-05-25, 1395/03/05
Registration timing:
retrospective
Last update:
2019-11-25, 1398/09/04
Update count:
1
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Registration date
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2016-05-25, 1395/03/05
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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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2016-03-08, 1394/12/18
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Expected recruitment end date
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2016-03-19, 1394/12/29
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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 omega-3 plus vitamin E supplementation compared to placebo on level of gene expression related to 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:
Smoking
Intake of omega-3 fatty acids and/or vitamin E supplements within the last 3 months
Intake of anti-inflammatory or antidiabetic drugs
Pregnancy
Other causes of hyperandrogenism and/or anovulation
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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 and after stratification for pre-intervention BMI and age, subjects will be randomly divided 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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Random assignment will be done by the use of computer-generated random numbers.
Ethics committees
1
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Ethics committee
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Approval date
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2016-03-07, 1394/12/17
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Ethics committee reference number
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IR.ARAKMU.REC.1394.335
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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Beck scor
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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
2
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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
3
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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
Secondary outcomes
1
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Description
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level of IL-1 gene expression
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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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level of IL-8 gene expression
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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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level of TNFα gene expression
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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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level of TGFB gene expression
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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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Gene expression of PPAR-gamma
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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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Gene expression of 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
Intervention groups
1
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Description
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Intervention group: Combined 1000 mg omega-3 fatty acids and 400 IU vitamin E, manufactured byBarij Essence, Kashan, Iran; once a day for 12 weeks, administered 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 manufactured by Barij Essence, Kashan, Iran; once a day for 12 weeks, administered 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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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