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

NCT06970821 | Completed

• 1 other identifier: 776/28.09.2023
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Vitamin D Deficiency; Insulin Resistance

Keywords

Adolescents; Polycystic Ovary Syndrome; Metabolic Markers; Visceral fat

Outcome Measures

Primary Outcomes (5)

• Serum 25(OH)D Level at Baseline

  Concentration of 25-hydroxyvitamin D \[25(OH)D\] in serum measured in ng/mL using chemiluminescent immunoassay.

  At enrollment

• Body Mass Index (BMI) at Baseline

  Body mass index calculated as weight in kilograms divided by the square of height in meters (kg/m²).

  At enrollment

• HOMA-IR Value at Baseline

  Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated as \[fasting glucose (mg/dL) × fasting insulin (µU/mL)\] / 405.

  At enrollment

• Serum Lipid Profile at Baseline

  Fasting serum levels of total cholesterol, HDL, LDL, and triglycerides measured in mg/dL.

  At enrollment

• Visceral Adipose Tissue Thickness, Subcutaneous Adipose Tissue Thickness

  The transducer was placed transversely, 1 cm above the umbilicus on the xiphoid-pubic line

  At enrollment

Study Arms (2)

PCOS Group

Adolescents diagnosed with PCOS according to NIH criteria, evaluated for metabolic parameters and vitamin D status.

Control Group

Healthy adolescents without PCOS, evaluated with the same clinical, biochemical, and ultrasound measures.

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female adolescents aged 13 to 19 years who attended the adolescent gynecology outpatient clinic of a tertiary care hospital. Participants included adolescents diagnosed with polycystic ovary syndrome based on NIH criteria and age-matched healthy controls. All participants had attained menarche at least two years prior to enrollment.

You may qualify if:

• Female adolescents aged 13 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

Bağcılar Training and Research Hospital

Istanbul, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Vitamin D Deficiency; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Nese Hayirlioglu

  Bagcilar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 14, 2025
• Study Start: March 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

TU (1)