Investigating Vitamin D Levels and Metabolic Health in Adolescents with PCOS
A Prospective Case-Control Study Investigating Serum Vitamin D Status and Metabolic Markers in Adolescent Girls With PCOS
This study is testing how vitamin D levels relate to weight and metabolic health in teenagers with polycystic ovary syndrome (PCOS) compared to healthy teens.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 110 (estimated) |
| Ages | 12 Years to 19 Years |
| Sex | Female |
| Sponsor | Bagcilar Training and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06970821 on ClinicalTrials.gov |
What this trial studies
This observational study examines the relationship between serum vitamin D levels, visceral fat thickness, and metabolic parameters in adolescents diagnosed with polycystic ovary syndrome (PCOS) compared to healthy controls. It includes 70 adolescents with PCOS and 40 age-matched healthy adolescents aged 12 to 19 years. Participants undergo clinical assessments, including body measurements and biochemical evaluations of glucose, insulin, and lipid profiles. The study aims to uncover potential links between vitamin D deficiency and metabolic issues in adolescents with PCOS.
Who should consider this trial
Good fit: Ideal candidates are female adolescents aged 12 to 19 years with a diagnosis of PCOS or healthy adolescents with regular menstrual cycles.
Not a fit: Patients with endocrine disorders or those on medications affecting vitamin D metabolism or insulin sensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the metabolic risks associated with PCOS and inform potential interventions for vitamin D deficiency in affected adolescents.
How similar studies have performed: While there is emerging evidence regarding vitamin D's role in metabolic health, this specific approach in adolescents with PCOS is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Istanbul
- Bağcılar Training and Research Hospital — Istanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: Nese Hayirlioglu — Bagcilar Training and Research Hospital
- Study coordinator: Nursen Kurtoglu
- Email: kurtoglunursen@yahoo.com
- Phone: +90 533 2330701
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.