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

NCT07723443 | Completed

• 1 other identifier: 63
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

Polycystic ovary syndrome; Ezrin; Vitamin E; Folic acid; Hormonal profile; Free androgen index

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

Vitamin E group

ACTIVE COMPARATOR

The patients will receive 400 IU of vitamin E once daily for one month

Dietary Supplement: Vitamin E 400

Folic acid group

ACTIVE COMPARATOR

The patients will receive 5 mg of folic acid once daily for one month

Dietary Supplement: Folic Acid 5 Mg Oral Tablet

The combination group

EXPERIMENTAL

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; Dietary Supplement: Folic Acid 5 Mg Oral Tablet

Healthy control

NO INTERVENTION

Interventions

Vitamin E 400 DIETARY_SUPPLEMENT

Soft gelatin capsule of Vitamin E each contains 400 IU

The combination group; Vitamin E group

Folic Acid 5 Mg Oral Tablet DIETARY_SUPPLEMENT

Film coated tablet of 5 mg folic acid

Folic acid group; The combination group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Al-Mustansiriyah University: lead

Study Sites (1)

Kamal Al-Samarrai Specialized Hospital

Baghdad, Al-Rusafa, 10064, Iraq

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Folic Acid; Tablets

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 23, 2026
• Study Start: July 1, 2025
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

IR (1)