Clinical trial · Observational
Is There Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?
Is There An Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?
NCT02803476CI-TRIAL-00022634unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary aim of the current study is to clarify whether serum vitamin D levels \[25(OH)D3\] have a temporal association with insulin resistance and/or insulin sensitivity in PCOS women versus healthy ones. To achieve this aim, the investigators will conduct a prospective observational study involving obese and lean PCOS women in comparison to obese and lean healthy subjects living in Cairo, Egypt.
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
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Polycystic ovary syndrome (PCOS) female patients. 20-35 years of age.
- label
- Controls
- description
- Non-PCOs female subjects. 20-35 years of age.
Primary outcomes (1)
- measure
- Quantitative Insulin Sensitivity Check Index (QUICKI)
- timeFrame
- After sample collection and analysis, through study completion, an average of 20 weeks.
- description
- A validated measure of Insulin sensitivity based on fasting Insulin (uIU/mL) and Glucose (mg/dL).
Secondary outcomes (3)
- measure
- Fasting Plasma Insulin
- timeFrame
- 12 hours of fasting.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 35 Years
Show eligibility criteria text
PCOS female patients criteria: Inclusion Criteria: * PCOS will be diagnosed in accordance with Rotterdam criteria. * No relevant systemic diseases e.g. hypertension, DM. Exclusion Criteria: * Androgen secreting tumor. * Cushing syndrome. * Congenital adrenal hyperplasia. * Hyperprolactinemia. * Virilism. * Pregnant or nursing. * Conditions known to affect Vitamin D deficiency like renal disease, liver disease, gastrointestinal problems and malnutrition. * Taking vitamin D or calcium supplements. * Untreated hypothyroidism or hyperthyroidism. Non-PCOS female subjects criteria: * Regular menstrual cycles * Not suffering from any conditions known to affect Vitamin D deficiency like renal disease, liver disease, gastro-Intestinal problems and malnutrition. * Not taking vitamin D or calcium supplements. * No relevant systemic diseases e.g. hypertension, DM.
References
Publications (31)
- BACKGROUNDYildizhan R, Kurdoglu M, Adali E, Kolusari A, Yildizhan B, Sahin HG, Kamaci M. Serum 25-hydroxyvitamin D concentrations in obese and non-obese women with polycystic ovary syndrome. Arch Gynecol Obstet. 2009 Oct;280(4):559-63. doi: 10.1007/s00404-009-0958-7. Epub 2009 Feb 13. PMID 19214546
- BACKGROUNDBoucher BJ, Mannan N, Noonan K, Hales CN, Evans SJ. Glucose intolerance and impairment of insulin secretion in relation to vitamin D deficiency in east London Asians. Diabetologia. 1995 Oct;38(10):1239-45. doi: 10.1007/BF00422375. PMID 8690178
- BACKGROUNDOrwoll E, Riddle M, Prince M. Effects of vitamin D on insulin and glucagon secretion in non-insulin-dependent diabetes mellitus. Am J Clin Nutr. 1994 May;59(5):1083-7. doi: 10.1093/ajcn/59.5.1083. PMID 8172095
- BACKGROUNDThomson RL, Spedding S, Buckley JD. Vitamin D in the aetiology and management of polycystic ovary syndrome. Clin Endocrinol (Oxf). 2012 Sep;77(3):343-50. doi: 10.1111/j.1365-2265.2012.04434.x. PMID 22574874
- BACKGROUNDDunaif A. Insulin resistance and the polycystic ovary syndrome: mechanism and implications for pathogenesis. Endocr Rev. 1997 Dec;18(6):774-800. doi: 10.1210/edrv.18.6.0318. PMID 9408743
- BACKGROUNDSelimoglu H, Duran C, Kiyici S, Ersoy C, Guclu M, Ozkaya G, Tuncel E, Erturk E, Imamoglu S. The effect of vitamin D replacement therapy on insulin resistance and androgen levels in women with polycystic ovary syndrome. J Endocrinol Invest. 2010 Apr;33(4):234-8. doi: 10.1007/BF03345785. Epub 2009 Oct 9. PMID 19820295
- BACKGROUNDArdabili HR, Gargari BP, Farzadi L. Vitamin D supplementation has no effect on insulin resistance assessment in women with polycystic ovary syndrome and vitamin D deficiency. Nutr Res. 2012 Mar;32(3):195-201. doi: 10.1016/j.nutres.2012.02.001.