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COMPLETED
NCT07723443
NA

Effects of Folic Acid and Vitamin E on Hormones in Polycystic Ovary Syndrome

Sponsor: Al-Mustansiriyah University

View on ClinicalTrials.gov

Summary

The goal of this prospective comparative interventional study is to evaluate serum Ezrin levels and investigate the effects of one-month supplementation with vitamin E and folic acid in Iraqi women of reproductive age diagnosed with polycystic ovary syndrome (PCOS) evaluating for infertility, as well as healthy controls. The main questions it aims to answer are: * Do serum Ezrin levels differ between women with PCOS and healthy controls, and do these levels change following intervention? * What impact does one-month supplementation with vitamin E, folic acid, or their combination have on hormonal profiles (such as LH, FSH, testosterone, and SHBG) and clinical symptoms? If there is a comparison group: Researchers will compare three PCOS treatment arms (vitamin E 400 IU/day, folic acid 5 mg/day, and a combination of both) to each other and to a baseline healthy control group to see if the interventions partially improve androgen bioavailability, reproductive hormonal balance, clinical symptoms like hirsutism, and whether they modulate circulating serum Ezrin levels. Participants will: * Take their assigned daily oral intervention (vitamin E, folic acid, or a combination of the two) for a duration of one month. * Provide venous blood samples before treatment begins and after the one-month period to measure serum Ezrin concentrations and reproductive hormones. * Undergo clinical and anthropometric assessments to document variables including body mass index (BMI), waist-to-hip ratio (WHR), blood pressure, acne, hirsutism, and menstrual cycle regularity.

Official title: Effects of Folic Acid and Vitamin E on Serum Ezrin and Hormonal Profile in Women With Polycystic Ovary Syndrome

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

207

Start Date

2025-07-01

Completion Date

2026-02-10

Last Updated

2026-07-23

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Vitamin E 400

Soft gelatin capsule of Vitamin E each contains 400 IU

DIETARY_SUPPLEMENT

Folic Acid 5 Mg Oral Tablet

Film coated tablet of 5 mg folic acid

Locations (1)

Kamal Al-Samarrai Specialized Hospital

Baghdad, Al-Rusafa, Iraq