Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New Haven, Connecticut 06520


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.


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.



Primary Contact:

Principal Investigator
Lubna Pal, MBBS,MRCOG,MSc.
Yale University

Backup Contact:


Location Contact:

New Haven, Connecticut 06520
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.