Clinical trial · Interventional
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
NCT00743574CI-TRIAL-00053261completedN/AResults postedClinicalTrials.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 investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI \> 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels \< 20 ng/mL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovarian Syndrome | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elemental Calcium | Dietary Supplement | — | UNRESOLVED |
| Medroxyprogesterone (Provera) | Drug | — | UNRESOLVED |
| Vitamin D2 (Ergocalciferol) | Dietary Supplement | — | UNRESOLVED |
| Vitamin D3 (Cholecalciferol) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vitamin D plus Calcium (Ca) supplementation
- interventionNames
- Dietary Supplement: Vitamin D2 (Ergocalciferol)
- Drug: Medroxyprogesterone (Provera)
- Dietary Supplement: Vitamin D3 (Cholecalciferol)
- Dietary Supplement: Elemental Calcium
Primary outcomes (5)
- measure
- Serum HbA1C at 3 Months
- timeFrame
- Completion
- description
- Fasting HbA1C levels at study completion after 3 month treatment
- measure
- Fasting Insulin Levels at Study Completion After 3 Month Treatment
- timeFrame
- 3 months intervention
- description
- Fasting insulin levels at study completion after 3 month treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women (ages 18-40 years) with normal thyroid function and prolactin levels. * PCOS diagnosis based on Rotterdam criteria: presence of at least 2 of the following criteria: * oligomenorrhea-menstrual cycles \> 35 day intervals * hyperandrogenemia (elevated serum testosterone \[free or total\] \&/or androstenedione levels) or features of hyperandrogenism i.e. acne or hirsuitism \[Ferriman-Gallaway score \> 3\] * polycystic ovaries on vaginal ultrasound as defined by ESHRE/ASRM criteria (ovarian volume ≥ 10mL or ≥ 12 follicles of diameter between 2-9mm in at least one ovary) * Overweight (BMI ≥ 27 Kg/m2) * Biochemical evidence of Vitamin D insufficiency (i.e. serum 25 OHD levels \< 20ng/mL) Exclusion Criteria: * Pregnancy * Known causes of oligomenorrhea other than PCOS, e.g. hypothyroidism/Cushing's Disease/late onset congenital adrenal hyperplasia (fasting 17-alphahydroxyprogesterone levels \< 200ng/dL) * Use of hormonal treatment (birth control pill/patch/depot medroxyprogesterone/medroxyprogesterone) within 3 months of the study onset. * Use insulin sensitizers (metformin, sulfonylureas, TZDs, incretins) within 3 months of the study onset. * Use of lipid lowering agents or medications known to influence insulin sensitivity (e.g. niacin, corticosteroids, beta blockers, calcium channel blockers, thiazide diuretics) or influence serum androgens (estrogen, anti-androgens, androgens) within 3 months of the study onset. * Known history of renal calculi or current use of Calcium and Vitamin D supplements. * Spanish Speaking.
References
Publications (2)
- RESULTPal L, Berry A, Coraluzzi L, Kustan E, Danton C, Shaw J, Taylor H. Therapeutic implications of vitamin D and calcium in overweight women with polycystic ovary syndrome. Gynecol Endocrinol. 2012 Dec;28(12):965-8. doi: 10.3109/09513590.2012.696753. Epub 2012 Jul 11. PMID 22780885
- DERIVEDNardell M, Chhabra A, Pal L. Excluded, not dismissed: enhancing benefit in clinical research. Contemp Clin Trials. 2013 Jan;34(1):70-3. doi: 10.1016/j.cct.2012.08.013. Epub 2012 Sep 7. PMID 22981957