Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Calcium; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Medroxyprogesterone; Medroxyprogesterone Acetate; Vitamin D; Vitamins

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-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.