Effects of Folic Acid and Vitamin E on Serum Ezrin and Hormonal Profile in Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 1
- 主要终点
- Ezrin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of reproductive age with confirmed PCOS who presented with primary or secondary infertility
排除标准
- •Patients with other endocrine disorders that could affect hormonal status, pregnancy, or recent use of hormonal or antioxidant therapy before enrollment
结局指标
主要结局
Ezrin
时间窗: At baseline after one month of treatment
Serum levels of Ezrin
Follicle-stimulating hormone
时间窗: At baseline and after one month of treatment
Serum levels of follicle-stimulating hormone
Luteinizing hormone
时间窗: At baseline after one month of treatment
Serum levels of luteinizing hormone
Prolactin
时间窗: At baseline after one month of treatment
Serum levels of prolactin hormone
Estradiol
时间窗: At baseline after one month of treatment
Serum levels of estradiol hormone
Thyroid-stimulating hormone
时间窗: At baseline after one month of treatment
Serum levels of thyroid-stimulating hormone
Total testosterone
时间窗: At baseline after one month of treatment
Serum levels of total testosterone
Sex hormone-binding globulin
时间窗: At baseline after one month of treatment
Serum levels of sex hormone-binding globulin
次要结局
未报告次要终点
研究者
Huda Jaber Waheed
Head of Department
Al-Mustansiriyah University
