Analysis of Vitamin D and VDR Expression in Women With Advanced Endometriosis: A Case-Control Study in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Vitamin D level
研究概览
简要总结
The goal of this cross-sectional prospective matching study is to evaluate whether serum vitamin D levels and vitamin D receptor (VDR) expression are associated with the presence and severity of endometriosis in women of reproductive age.
The main questions it aims to answer are:
- Is there a difference in serum 25-hydroxyvitamin D [25(OH)D] levels between women with endometriosis and healthy controls?
- Is there a correlation between serum vitamin D levels and VDR expression in endometriotic tissues?
- Is there an association between vitamin D status and the severity of endometriosis based on the revised American Society for Reproductive Medicine (rASRM) staging?
Researchers will compare participants with endometriosis to matched healthy controls (1:2 ratio).
Participants will:
- Provide blood samples for serum 25(OH)D measurement.
- Undergo surgical tissue sampling (for the endometriosis group) to assess VDR expression using immunohistochemistry staining.
- Complete structured questionnaires regarding sun exposure, lifestyle, and clinical characteristics.
详细描述
This cross-sectional study aims to investigate the association between serum vitamin D levels and endometriosis, and to further explore the expression of vitamin D receptor (VDR) in endometriotic tissues using immunohistochemistry.
The study enrolled reproductive-aged women diagnosed with endometriosis who underwent laparoscopic surgery and compared them with matched healthy controls based on age and BMI.
Serum levels of 25-hydroxyvitamin D [25(OH)D] were measured using a standardized laboratory assay. Endometriotic tissue samples obtained during surgery were analyzed for VDR expression, qualitative-quantified using the H-score method in both stroma and epithelial compartments. Clinical data, including revised American Society for Reproductive Medicine (rASRM) staging, were used to assess disease severity. Additional data were collected via structured interviews covering sun exposure, reproductive history, lifestyle, and hormonal treatment.
Tissue staining and scoring were reviewed by two blinded pathologists to ensure reproducibility. Data entry validation was performed by cross-checking case report forms with original clinical records, and double data entry methods were used to minimize errors.
Sample size was determined based on prior effect size estimates from published literature, aiming to achieve a power of 80% and significance level of 5%. The study population was sufficient to detect a clinically meaningful difference in vitamin D status between cases and controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- •Received vitamin D supplements within the past 3 months prior to volunteering.
- •History of chronic infectious diseases.
- •Previously treated for autoimmune diseases.
- •History of polycystic ovarian.
- •History of bone disorders or receiving medications affecting bones.
- •Irregular menstrual cycles or absence of menstruation for more than 3 months up to 1 year.
结局指标
主要结局
Vitamin D level
时间窗: At enrollment
Vitamin D status
次要结局
- rASRM(Intra operation)
- Vitamin D receptor(Up to 4 weeks after surgery)
研究者
Vitet Layanun
Dr.Vitet Layanun
Khon Kaen University