Effect of supplementation in treatment of women with polycystic ovary syndrome

Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201704245623N114

Enrollment

Registered

2017-04-25

Start date

2017-02-21

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Polycystic ovarian syndrome. Polycystic ovarian syndrome

Interventions

Intervention 1: Intervention group: 2000 mg omega-3 daily (Barij Essence, Kashan, Iran) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally. Intervention 2: Control group

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 Written informed consent

Exclusion criteria

Exclusion criteria: Pregnancy Adrenal hyperplasia Androgen secreting tumors Hyperprolactinemia Thyroid dysfunction Diabetes or impaired glucose tolerance

Design outcomes

Primary

Measure	Time frame
Total testosterone. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.	—

Secondary

Measure	Time frame
Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;SHBG. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Beck score. 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.	—

Measure

Time frame

Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Expressed levels of IL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;SHBG. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Beck score. 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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5546 3378

Outcome results

None listed

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