Effects of Folic Acid and Vitamin E on Serum Ezrin and Hormonal Profile in Women With Polycystic Ovary Syndrome
| Registry | NCT07723443 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 207 (Actual) |
| Sponsor | Al-Mustansiriyah University (Other) |
| Conditions | PCOS (Polycystic Ovary Syndrome) |
| Interventions | Vitamin E 400, Folic Acid 5 Mg Oral Tablet (Dietary supplement) |
| Dates | start 2025-07-01, primary completion 2026-02-10, completion 2026-02-10, first posted 2026-07-23, last updated 2026-07-23 |
| Locations | 1 site in Iraq |
Related Papers Related Patents Related Grants Related Experts
All trials for PCOS (Polycystic Ovary Syndrome) All trials of Vitamin E 400 All trials of Folic Acid 5 Mg Oral Tablet
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Vitamin E group | Active comparator | Dietary Supplement: Vitamin E 400 | The patients will receive 400 IU of vitamin E once daily for one month |
| Folic acid group | Active comparator | Dietary Supplement: Folic Acid 5 Mg Oral Tablet | The patients will receive 5 mg of folic acid once daily for one month |
| The combination group | Experimental | Dietary Supplement: Vitamin E 400; Dietary Supplement: Folic Acid 5 Mg Oral Tablet | The patients will receive 5 mg of folic acid and 400 IU of vitamin E once daily for one month |
| Healthy control | No intervention |
Sex: Female, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Kamal Al-Samarrai Specialized Hospital | Baghdad, Al-Rusafa | Iraq |