Clinical trial · Observational
Association of Vitamin D Status With Metabolic Markers in Adolescents With Polycystic Ovary Syndrome
A Prospective Case-Control Study Investigating Serum Vitamin D Status and Metabolic Markers in Adolescent Girls With PCOS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- PCOS Group
- description
- Adolescents diagnosed with PCOS according to NIH criteria, evaluated for metabolic parameters and vitamin D status.
- label
- Control Group
- description
- Healthy adolescents without PCOS, evaluated with the same clinical, biochemical, and ultrasound measures.
Primary outcomes (5)
- measure
- Serum 25(OH)D Level at Baseline
- timeFrame
- At enrollment
- description
- Concentration of 25-hydroxyvitamin D \[25(OH)D\] in serum measured in ng/mL using chemiluminescent immunoassay.
- measure
- Body Mass Index (BMI) at Baseline
- timeFrame
- At enrollment
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 13 Years
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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).
References
Publications (0)
Data not yet available