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

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

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.

Study Overview

• Status: Completed
• Conditions: PCOS (Polycystic Ovary Syndrome)
• Intervention / Treatment: Dietary supplement: Vitamin E 400; Dietary supplement: Folic Acid 5 Mg Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Al-Rusafa
    • Baghdad, Al-Rusafa, Iraq, 10064
      • Kamal Al-Samarrai Specialized Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women of reproductive age with confirmed PCOS who presented with primary or secondary infertility

Exclusion Criteria:

• Patients with other endocrine disorders that could affect hormonal status, pregnancy, or recent use of hormonal or antioxidant therapy before enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy control
Active Comparator: Vitamin E group; The patients will receive 400 IU of vitamin E once daily for one month	Dietary supplement: Vitamin E 400; Soft gelatin capsule of Vitamin E each contains 400 IU
Active Comparator: Folic acid group; The patients will receive 5 mg of folic acid once daily for one month	Dietary supplement: Folic Acid 5 Mg Oral Tablet; Film coated tablet of 5 mg folic acid
Experimental: The combination group; The patients will receive 5 mg of folic acid and 400 IU of vitamin E once daily for one month	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ezrin	Serum levels of Ezrin	At baseline after one month of treatment
Follicle-stimulating hormone	Serum levels of follicle-stimulating hormone	At baseline and after one month of treatment
Luteinizing hormone	Serum levels of luteinizing hormone	At baseline after one month of treatment
Prolactin	Serum levels of prolactin hormone	At baseline after one month of treatment
Estradiol	Serum levels of estradiol hormone	At baseline after one month of treatment
Thyroid-stimulating hormone	Serum levels of thyroid-stimulating hormone	At baseline after one month of treatment
Total testosterone	Serum levels of total testosterone	At baseline after one month of treatment
Sex hormone-binding globulin	Serum levels of sex hormone-binding globulin	At baseline after one month of treatment

Collaborators and Investigators

• Sponsor: Al-Mustansiriyah University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Actual): February 10, 2026
• Study Completion (Actual): February 10, 2026

Study Registration Dates

• First Submitted: July 19, 2026
• First Submitted That Met QC Criteria: July 19, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 19, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Vitamin E; Folic acid; Polycystic ovary syndrome; Ezrin; Free androgen index; Hormonal profile
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Dosage Forms; Pterins; Pteridines; Folic Acid; Tablets
• Other Study ID Numbers: 63

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No