Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Completed · Not applicable
Conditions studied: Polycystic Ovarian Syndrome, Vitamin D Deficiency
In brief
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).
Key facts
- Study ID
- NCT00743574
- Run by
- Yale University
- People needed
- 36
- Starts
- 2008-08-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2021-08-13
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Yale-New Haven Hospital-Women's Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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