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Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome) - NCT00743574-06520(Clinical Trial 239454)



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City:  New Haven
State:  
CT
Zip Code: 06520
Conditions: Polycystic Ovarian Syndrome - Vitamin D Deficiency
Purpose: The investigators aim is to conduct a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation use in overweight (BMI > 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and have Vitamin D insufficiency, as reflected by serum 25-hydroxyl (25-OH) Vitamin D (serum levels < 20 ng/mL).
Study summary: We hypothesize that administering optimal daily doses of Vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of Ca, both per oral (PO), over a three month period in women with PCOS will yield significant results in the improvement of their condition.
Criteria: 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-alphahydroxylprogesterone 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.
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Data Source: ClinicalTrials.gov
Date Processed: April 13, 2010
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