Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study
NCT ID: NCT06289257
Last Updated: 2025-07-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
108 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-05-06
Study Completion Date
2024-12-23
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Endometriosis
Vitamin D Deficiency/Insufficiency
Vitamin D Status
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Endometriosis
Women with endometriosis
Vitamin D level
Intervention Type
DIAGNOSTIC_TEST
Vitamin D level in blood
Vitamin D receptor
Intervention Type
OTHER
Vitamin D receptor in endometriosis tissue
Control
Healthy women
Vitamin D level
Intervention Type
DIAGNOSTIC_TEST
Vitamin D level in blood
Interventions
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Vitamin D level
Vitamin D level in blood
Intervention Type
DIAGNOSTIC_TEST
Vitamin D receptor
Vitamin D receptor in endometriosis tissue
Intervention Type
OTHER
Other Intervention Names
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Vitamin D status
Eligibility Criteria
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Inclusion Criteria
* Women diagnosed with ectopic endometriotic tissue:
* Have a scheduled surgery appointment at Sri Nakarin Hospital.
* Are aged 18 years or older.
* 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.
* Have a scheduled surgery appointment at Sri Nakarin Hospital.
* Are aged 18 years or older.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Khon Kaen University
OTHER
Sponsor Role
lead
Responsible Party
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Vitet Layanun
Dr.Vitet Layanun
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Site Status
Countries
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Thailand
References
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Other Identifiers
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HE661574
Identifier Type: -
Identifier Source: org_study_id
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Effect of Vitamin D on Outcome of Assisted Reproductive Technology(ART);
NCT03804294
UNKNOWN
Effect of Vitamin D on the Size of Fibroids in Women With Vitamin D Deficiency
NCT03991078
COMPLETED
Correlation Between Serum Vitamin D3 and Incidence of Uterine Leiomyoma
NCT05151393
UNKNOWN
Vitamin D in Ectopic Pregnancies
NCT03894735
COMPLETED
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes
NCT00812578
COMPLETED
PHASE2
Vitamin D Influence on Oocyte Donation
NCT02341365
COMPLETED
Correlation of Vitamin D Levels in Early Pregnancy With Gestational Diabetes and Pregnancy Outcomes
NCT05212519
UNKNOWN
Vitamin D Supplementation and Male Infertility: The CBG-study a Randomized Clinical Trial
NCT01304927
COMPLETED
PHASE2/PHASE3
The Cohort Study of the Correlation Between Serum 25(OH)D Level and Pregnancy Outcome
NCT05824897
UNKNOWN
Vitamin D Status Among Infertile Women in Sweden
NCT05848349
COMPLETED
Association Between Vitamin D Receptor Polymorphism and Serum Vitamin D Levels in Children With Low-Energy Fractures
NCT02805647
COMPLETED
Vitamin D Deficit in Women With Uterine Fibroids
NCT04030182
COMPLETED
Vitamin D Deficiency in Obese Adolescent Girls and Influence of Vitamin D on Insulin Secretion and Sensitivity
NCT00850694
COMPLETED
Serum Levels of 25-Hydroxy Vitamin D in Patients With Moderate and Severe Erectile Dysfunction
NCT03867929
COMPLETED
Vitamin D Status and Muscle Function
NCT02858882
COMPLETED
Familial Clustering of Vitamin D Deficiency Via Shared Environment: The Korean National Health And Nutrition Examination Survey 2008-2012
NCT03349879
COMPLETED
Vitamin D Deficiency of Couples and Infertility
NCT03305510
COMPLETED
Effects of Vitamin D3 Versus 25OHD3 on Mineral Metabolism and Immune Function
NCT02091219
COMPLETED
EARLY_PHASE1
A Cross Sectional Evaluation of Vitamin D Status and Ovarian Reserve Markers
NCT05137964
COMPLETED
Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 on Transcriptomic Changes of Low Vitamin D Responders
NCT03537027
COMPLETED
PHASE1