Association of Vitamin D Status With Metabolic Markers in Adolescents With Polycystic Ovary Syndrome

Recruiting

• Conditions: Polycystic Ovary Syndrome; Vitamin D Deficiency; Insulin Resistance

• Registration Number: NCT06970821
• Lead Sponsor: Bagcilar Training and Research Hospital

Brief Summary

This prospective cross-sectional case-control study aims to investigate the relationship between serum vitamin D levels, visceral adipose tissue (VAT) thickness, and metabolic parameters in adolescents diagnosed with polycystic ovary syndrome (PCOS), compared to healthy controls. The study includes 70 adolescents with PCOS and 40 age-matched healthy adolescents, all aged between 12 and 19 years, who attended the adolescent gynecology outpatient clinic of a tertiary care hospital. Serum 25-hydroxy vitamin D \[25(OH)D\] levels, fasting glucose, fasting insulin, lipid profiles, anthropometric measurements, and ultrasound-based VAT thickness were assessed. The study seeks to explore potential associations between vitamin D deficiency and metabolic dysregulation in adolescent PCOS patients and to better understand the early cardiometabolic risks associated with PCOS during adolescence.

Detailed Description

Polycystic ovary syndrome (PCOS) is a common endocrine disorder affecting women of reproductive age, with manifestations often beginning during adolescence. It is associated not only with reproductive abnormalities but also with significant metabolic complications, including insulin resistance, obesity, dyslipidemia, and an increased risk of metabolic syndrome. Recent evidence suggests that vitamin D deficiency may play a role in the metabolic dysfunction observed in PCOS, although the exact mechanisms remain under investigation.

This prospective cross-sectional case-control study aims to evaluate the relationship between serum 25-hydroxy vitamin D \[25(OH)D\] levels, visceral adipose tissue (VAT) thickness, and metabolic parameters in adolescents with PCOS compared to healthy controls. The study population includes 70 adolescents diagnosed with PCOS according to the NIH criteria and 40 age-matched healthy adolescents, all aged between 12 and 19 years, attending a tertiary care hospital's adolescent gynecology clinic.

Participants underwent detailed clinical and anthropometric assessments, including measurements of body mass index (BMI), waist circumference, hip circumference, and waist-to-hip ratio (WHR). Biochemical evaluations included fasting plasma glucose, fasting insulin, lipid profiles, and serum 25(OH)D levels. Insulin resistance was assessed using the HOMA-IR .

VAT and subcutaneous adipose tissue (SAT) thickness were measured by transabdominal ultrasound, utilizing a standardized technique for consistency. All ultrasound measurements were performed by the same experienced investigator to ensure reliability, and intraobserver agreement was assessed.

The primary objective of the study is to investigate potential associations between vitamin D deficiency and metabolic disturbances in adolescents with PCOS, focusing particularly on insulin resistance, lipid abnormalities, and visceral fat accumulation. The findings may contribute to a better understanding of early cardiometabolic risk in adolescents with PCOS and help in developing targeted preventive strategies.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2025-04-28
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Female adolescents aged 12 to 19 years
• Having attained menarche at least two years prior to enrollment
• For PCOS group: Diagnosis of polycystic ovary syndrome based on NIH criteria (presence of menstrual irregularity and clinical and/or biochemical hyperandrogenism)
• For Control group: Regular menstrual cycles (cycle interval 21-35 days) and no clinical or biochemical signs of hyperandrogenism.

Exclusion Criteria

• Use of medications affecting vitamin D metabolism, insulin sensitivity, or androgen levels within the past 6 months (e.g., oral contraceptives, insulin sensitizers, vitamin D supplements)
• Presence of endocrine disorders such as congenital adrenal hyperplasia, hyperprolactinemia, Cushing's syndrome, thyroid dysfunction.
• Chronic systemic diseases (e.g., diabetes mellitus, severe liver or kidney disease).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI) at Baseline	At enrollment	Body mass index calculated as weight in kilograms divided by the square of height in meters (kg/m²).
HOMA-IR Value at Baseline	At enrollment	Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated as \[fasting glucose (mg/dL) × fasting insulin (µU/mL)\] / 405.
Serum Lipid Profile at Baseline	At enrollment	Fasting serum levels of total cholesterol, HDL, LDL, and triglycerides measured in mg/dL.
Visceral Adipose Tissue Thickness	At enrollment	Measured using ultrasonography at the level of the umbilicus in the midline sagittal plane.
Serum 25(OH)D Level at Baseline	At enrollment	Concentration of 25-hydroxyvitamin D \[25(OH)D\] in serum measured in ng/mL using chemiluminescent immunoassay.

Trial Locations

Locations (1)

Bağcılar Training and Research Hospital; 🇹🇷 Istanbul, Turkey