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Completed

NCT Number: NCT00743574

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

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).

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Elemental Calcium

Dietary Supplement

1,000mg (or 2 tablets), PO, daily (supplements taken for three months)

Primary outcomes

  1. Serum HbA1C at 3 Months

    Time frame: Completion

    Fasting HbA1C levels at study completion after 3 month treatment

  2. Fasting Insulin Levels at Study Completion After 3 Month Treatment

    Time frame: 3 months intervention

    Fasting insulin levels at study completion after 3 month treatment

  3. Fasting Glucose Levels at Completion of Treatment, at 3 Months

    Time frame: 3 months

    Fasting glucose levels drawn after 3 months completion during oral GTT

  4. 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

    Time frame: 3 months

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

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

    Time frame: 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

Secondary outcomes

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

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Aug 29, 2008
Registry last updated
Aug 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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