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

Not Applicable

Completed

• Conditions: Vitamin D Deficiency; Polycystic Ovarian Syndrome
• Interventions: Dietary Supplement: Vitamin D2 (Ergocalciferol); Drug: Medroxyprogesterone (Provera); Dietary Supplement: Vitamin D3 (Cholecalciferol); Dietary Supplement: Elemental Calcium

• Registration Number: NCT00743574
• Lead Sponsor: Yale University

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 (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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-28
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2013-02-15
• Results First Submitted QC: 2013-06-20
• Results First Posted: 2013-07-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D plus Calcium (Ca) supplementation	Vitamin D2 (Ergocalciferol)	-
Vitamin D plus Calcium (Ca) supplementation	Elemental Calcium	-
Vitamin D plus Calcium (Ca) supplementation	Medroxyprogesterone (Provera)	-
Vitamin D plus Calcium (Ca) supplementation	Vitamin D3 (Cholecalciferol)	-

Primary Outcome Measures

Name	Time	Method
Serum HbA1C at 3 Months	Completion	Fasting HbA1C levels at study completion after 3 month treatment
Fasting Insulin Levels at Study Completion After 3 Month Treatment	3 months intervention	Fasting insulin levels at study completion after 3 month treatment
Fasting Glucose Levels at Completion of Treatment, at 3 Months	3 months	Fasting glucose levels drawn after 3 months completion during oral GTT
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	3 months	Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT
AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months	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 Outcome Measures

Name	Time	Method
Serum Levels of C-reactive Protein at Completion of 3 Months Treatment	3 months	Serum levels of C-reactive protein upon completion, at 3 months

Trial Locations

Locations (1)

Yale-New Haven Hospital-Women's Center; 🇺🇸 New Haven, Connecticut, United States