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.
Who can participate
Age range
13 Years – 19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.