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

Yale University

Status

Completed

Conditions

Vitamin D Deficiency

Polycystic Ovarian Syndrome

Treatments

Drug: Medroxyprogesterone (Provera)

Dietary Supplement: Vitamin D3 (Cholecalciferol)

Dietary Supplement: Vitamin D2 (Ergocalciferol)

Dietary Supplement: Elemental Calcium

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00743574

YCCI-CARE Grant #UL1RR024139

YaleU-0807003992

Details and patient eligibility

About

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).

Full description

We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of calcium, both per oral (PO), over a three month period will improve their metabolic picture, and possibly hormone profile.

Over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing vitamin D status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.

Enrollment

36 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.