Status:
COMPLETED
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Polycystic Ovarian Syndrome
Vitamin D Deficiency
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00743574
Start Date
August 1 2008
End Date
February 1 2013
Last Update
August 13 2021
Active Locations (1)
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1
Yale-New Haven Hospital-Women's Center
New Haven, Connecticut, United States, 06520-8063