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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Polycystic Ovarian Syndrome, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D2 (Ergocalciferol)
* Drug: Medroxyprogesterone (Provera)
* Dietary Supplement: Vitamin D3 (Cholecalciferol)
* Dietary Supplement: Elemental Calcium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D plus Calcium (Ca) supplementation<br> | Dietary Supplement: Vitamin D2 (Ergocalciferol)<br>* 50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)<br>Drug: Medroxyprogesterone (Provera)<br>* 10mg, PO, daily for ten days<br>Dietary Supplement: Vitamin D3 (Cholecalciferol)<br>* 2,000IU (or 2 tablets), PO, daily (supplements taken for three months)<br>Dietary Supplement: Elemental Calcium<br>* 1,000mg (or 2 tablets), PO, daily (supplements taken for three months)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum HbA1C at 3 Months | Fasting HbA1C levels at study completion after 3 month treatment | Completion | 
| Fasting Insulin Levels at Study Completion After 3 Month Treatment | Fasting insulin levels at study completion after 3 month treatment | 3 months intervention | 
| Fasting Glucose Levels at Completion of Treatment, at 3 Months | Fasting glucose levels drawn after 3 months completion during oral GTT | 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 | 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 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Levels of C-reactive Protein at Completion of 3 Months Treatment | Serum levels of C-reactive protein upon completion, at 3 months | 3 months |