Polycystic Ovary SyndromeNCT06970821
Association of Vitamin D Status With Metabolic Markers in Adolescents With Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome and Vitamin D Deficiency, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Vitamin D Deficiency, Insulin Resistance
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bağcılar Training and Research Hospital
Istanbul, 34200
About this study
Official title: A Prospective Case-Control Study Investigating Serum Vitamin D Status and Metabolic Markers in Adolescent Girls With PCOS
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.
Read the 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.
- Keywords
- Adolescents, Polycystic Ovary Syndrome, Metabolic Markers, Visceral fat
- Medical subject headings
- Polycystic Ovary Syndrome, Vitamin D Deficiency, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum 25(OH)D Level at Baseline
Concentration of 25-hydroxyvitamin D [25(OH)D] in serum measured in ng/mL using chemiluminescent immunoassay.
Measured: 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).
Measured: 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.
Measured: At enrollment
Serum Lipid Profile at Baseline
Fasting serum levels of total cholesterol, HDL, LDL, and triglycerides measured in mg/dL.
Measured: 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
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Mar 2024
- Primary completion15 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nursen Kurtoglu Aksoy, Bagcilar Training and Research Hospital
- Investigators
- Nese Hayirlioglu, Principal investigator, Bagcilar Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970821
- Sponsor's protocol ID
- 776/28.09.2023
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case-Control Study Investigating Serum Vitamin D Status and Metabolic Markers in Adolescent Girls With PCOS
- ClinicalTrials.gov ID
- NCT06970821
- Acronym / sponsor ID
- 776/28.09.2023
- Keywords
- Adolescents, Polycystic Ovary Syndrome, Metabolic Markers, Visceral fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum 25(OH)D Level at Baseline
Time frame: At enrollment
Concentration of 25-hydroxyvitamin D [25(OH)D] in serum measured in ng/mL using chemiluminescent immunoassay.
Body Mass Index (BMI) at Baseline
Time frame: 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
Time frame: 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
Time frame: At enrollment
Fasting serum levels of total cholesterol, HDL, LDL, and triglycerides measured in mg/dL.
Visceral Adipose Tissue Thickness, Subcutaneous Adipose Tissue Thickness
Time frame: At enrollment
The transducer was placed transversely, 1 cm above the umbilicus on the xiphoid-pubic line
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nese Hayirlioglu principal investigator
Bagcilar Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Vitamin D Deficiency, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum 25(OH)D Level at Baseline (time frame: At enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.