Completed

Analysis of Vitamin D and VDR Expression in Women With Advanced Endometriosis: A Case-Control Study in Thailand

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Urogenital Diseases+9

+ Genital Diseases

+ Avitaminosis

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2024
See protocol details

Summary

Principal SponsorKhon Kaen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleAnalysis of Vitamin D and VDR Expression in Women With Advanced Endometriosis: A Case-Control Study in Thailand
NCT06289257
Principal SponsorKhon Kaen University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Urogenital DiseasesGenital DiseasesAvitaminosisDeficiency DiseasesEndometriosisFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleNutrition DisordersNutritional and Metabolic DiseasesVitamin D DeficiencyMalnutritionFemale Urogenital Diseases

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

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

Suspended

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
CompletedOne Study Center