Analysis of Vitamin D and VDR Expression in Endometriosis: A Case-Control Study

NCT06289257 | Completed DMC

• 1 other identifier: HE661574
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis; Vitamin D Deficiency/Insufficiency; Vitamin D Status

Keywords

Vitamin D level; Endometriosis; Vitamin D receptor; rASRM; Immunohistochemistry; 25(OH)D

Outcome Measures

Primary Outcomes (1)

• Vitamin D level

  Vitamin D status

  At enrollment

Secondary Outcomes (2)

• rASRM

  Intra operation

• Vitamin D receptor

  Up to 4 weeks after surgery

Study Arms (2)

Endometriosis

Women with endometriosis

Diagnostic Test: Vitamin D level; Other: Vitamin D receptor

Control

Healthy women

Diagnostic Test: Vitamin D level

Interventions

Vitamin D level DIAGNOSTIC_TEST

Vitamin D level in blood

Also known as: Vitamin D status

Control; Endometriosis

Vitamin D receptor OTHER

Vitamin D receptor in endometriosis tissue

Endometriosis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thai women, reproductive age

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Khonkaen University

Khon Kaen, Changwat Khon Kaen, 40000, Thailand

Location

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for Vitamin D level\<25(OH)D, Calcium, Phosphate, Magnesium, Albumin, AST, ALT, Creatinine, Tissue for Anti VDR staining.

MeSH Terms

Conditions

Endometriosis; Vitamin D Deficiency

Interventions

Receptors, Calcitriol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Receptors, Cytoplasmic and Nuclear; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Vitet Layanun

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: March 1, 2024
• Study Start: May 6, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)