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

Yale University36 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovarian Syndrome Vitamin D Deficiency

Interventions

Vitamin D2 (Ergocalciferol)DIETARY_SUPPLEMENT

50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)

Medroxyprogesterone (Provera)DRUG

10mg, PO, daily for ten days

Vitamin D3 (Cholecalciferol)DIETARY_SUPPLEMENT

2,000IU (or 2 tablets), PO, daily (supplements taken for three months)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Yale-New Haven Hospital-Women's Center

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Serum HbA1C at 3 Months

Fasting HbA1C levels at study completion after 3 month treatment

Time frame: Completion

Fasting Insulin Levels at Study Completion After 3 Month Treatment

Fasting insulin levels at study completion after 3 month treatment

Time frame: 3 months intervention

Fasting Glucose Levels at Completion of Treatment, at 3 Months

Fasting glucose levels drawn after 3 months completion during oral GTT

Time frame: 3 months

AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months

Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT

Time frame: 3 months

AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months

AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT

Time frame: 3 months

Secondary Outcomes

Serum Levels of C-reactive Protein at Completion of 3 Months Treatment

Serum levels of C-reactive protein upon completion, at 3 months

Time frame: 3 months

Data from ClinicalTrials.gov

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