NCT07723443Completed
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 207 (actual)
- First submitted
- 19 Jul 2026
- Start date
- 1 Jul 2025
- Primary completion date
- 10 Feb 2026
- Lead sponsor
- Al-Mustansiriyah University
- NCT number
- NCT07723443
What you commit to
- Study type: Interventional
- Participants enrolled: 207
- From 1 Jul 2025 to the primary completion date, 10 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with other endocrine disorders that could affect hormonal status, pregnancy, or recent use of hormonal or antioxidant therapy before enrollment
Who the study is looking for
- Women of reproductive age with confirmed PCOS who presented with primary or secondary infertility
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kamal Al-Samarrai Specialized Hospital Coordinator of this site? Confirm its status | Baghdad | Iraq | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.