Analysis of Vitamin D and VDR Expression in Women With Advanced Endometriosis: A Case-Control Study in Thailand
Data Collection
Collected from today forward - ProspectiveUrogenital Diseases+9
+ Genital Diseases
+ Avitaminosis
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: May 6, 2024
Actual date on which the first participant was enrolled.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. Missing data were managed using complete case analysis and sensitivity checks. For secondary outcomes, subgroup analyses were conducted based on categorized vitamin D levels (normal, insufficiency, deficiency, severe deficiency). Statistical analysis included: * Descriptive statistics for demographic and clinical characteristics. * Conditional logistic regression or non-parametric equivalents for between-group comparisons. * Logistic regression models to estimate the odds ratios for severe endometriosis by vitamin D status. * Correlation analyses between serum vitamin D levels, VDR expression (H-scores), and rASRM scores. All analyses were performed using STATA version 18.5. The findings aim to clarify the potential role of vitamin D and its receptor in endometriosis pathogenesis and to inform future interventional studies and clinical practice.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.108 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria Endometriosis Group: * Women diagnosed with ectopic endometriotic tissue: * Have a scheduled surgery appointment at Sri Nakarin Hospital. * Are aged 18 years or older. Inclusion Criteria Control Group: * Women undergoing examination at the outpatient department of Sri Nakarin Hospital. * No history of gynecological diseases or previous treatment for gynecological conditions associated with lower abdominal pain, infections, or abdominal masses at present. * Have undergone a gynecological examination within the past year, or if examined during the current visit, the results were normal. * Have undergone an ultrasound examination within the past year, or if examined during the current visit, the ultrasound results were normal. Exclusion Criteria: * 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University
Khon Kaen, ThailandOpen Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University in Google Maps