Effect of supplementation in treatment of women with polycystic ovary syndrome

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201605215623N79

Enrollment

Registered

2016-05-25

Start date

2016-03-08

Completion date

Unknown

Last updated

2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: 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. Intervention 2: Control group: Placebo manufactured by Barij Essence, Kashan, Iran

once a day for 12 weeks, administered orally.

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with PCOS according to Rotterdam criteria aged 18 to 40 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Beck scor. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;GHQ score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.;DASS-28 score. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Questionnaire.	—

Secondary

Measure	Time frame
Level of IL-1 gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Level of IL-8 gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Level of TNFa gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Level of TGFB gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Gene expression of PPAR-gamma. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Gene expression of GLUT-1. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.	—

Measure

Time frame

Level of IL-1 gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Level of IL-8 gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Level of TNFa gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Level of TGFB gene expression. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Gene expression of PPAR-gamma. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Gene expression of GLUT-1. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026