Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of combined omega-3 fatty acid and vitamin E supplementation on hormonal profiles in patients with polycystic ovary syndrome (PCOS).
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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: 64 women with PCOS eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, 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, uncontrolled hypertension, hypo or hyperthyroidism, liver disease, androgen-secreting tumor, or hyperprolactinemia.
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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: Markers of insulin metabolism (primary outcomes) and hormonal parameters and other metabolic profiles (secondary outcomes).
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 was 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:
IRCT201511015623N57
Registration date:
2015-11-03, 1394/08/12
Registration timing:
registered_while_recruiting
Last update:
2019-10-31, 1398/08/09
Update count:
1
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Registration date
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2015-11-03, 1394/08/12
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2015-11-01, 1394/08/10
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Expected recruitment end date
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2015-11-11, 1394/08/20
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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 combined omega-3 fatty acid and vitamin E supplementation compared with the placebo on hormonal profiles 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
Uncontrolled hypertension
Hypo or hyperthyroidism
Liver disease
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:
64
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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=32) or placebo (n=32). 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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2015-10-28, 1394/08/06
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Ethics committee reference number
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IR.Kaums.REC.1394.90
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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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 using HOMA formula
2
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Description
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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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Elisa kit
Secondary outcomes
1
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Description
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Testosterone
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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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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 after 12 weeks of intervention
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Method of measurement
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Elisa kit
3
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Description
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DHEAS
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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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Elisa kit
4
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Description
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FPG
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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
5
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Description
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Hirsutism
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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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Clinical observation
Intervention groups
1
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Description
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Control group: Placebo capsule, daily 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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Intervention group: Omega-3 fatty acid and vitamin E capsule, 1000 mg omega-3 fatty acid and 400 mg vitamin E, daily 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, 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