MedTrace Logo

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

NCT07723443 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2026-07-23

No results posted yet for this study

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)

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

Sponsors & Collaborators

  • Al-Mustansiriyah University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-02-10
Completion
2026-02-10

Countries

  • Iraq

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723443 on ClinicalTrials.gov