Effect of supplementation in treatment of women with polycystic ovary syndrome

Clinical trial of the effect of inofolic supplementation compared with metformin on parameters of mental health and oxidative stress in women with polycystic ovary syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201706065623N118

Enrollment

Registered

2017-07-04

Start date

2016-06-14

Completion date

Unknown

Last updated

2023-05-01

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: Inofolic supplements (Loli, Rome, Italy), 2000 mg myo-inositol, 200 µg folic acid, twice a day, for 12 weeks orally. Intervention 2: Control group: Metformin tablet

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients with PCOS according to Rotterdam criteria

Exclusion criteria

Exclusion criteria: Smokers The intake of folate supplements within the last 3 months Pregnant women Individuals with metabolic diseases Thyroid disease Hyperprolactinemia and hypercortisolemia

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
Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total glutathione. 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.	—

Measure

Time frame

Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total glutathione. 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.

—

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