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

Primary Purpose

Polycystic Ovarian Syndrome, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D2 (Ergocalciferol)
Medroxyprogesterone (Provera)
Vitamin D3 (Cholecalciferol)
Elemental Calcium
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovarian Syndrome

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale-New Haven Hospital-Women's Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D plus Calcium (Ca) supplementation

Arm Description

Outcomes

Primary Outcome Measures

Serum HbA1C at 3 Months
Fasting HbA1C levels at study completion after 3 month treatment
Fasting Insulin Levels at Study Completion After 3 Month Treatment
Fasting insulin levels at study completion after 3 month treatment
Fasting Glucose Levels at Completion of Treatment, at 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
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
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

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

Full Information

First Posted
August 28, 2008
Last Updated
August 11, 2021
Sponsor
Yale University
Collaborators
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00743574
Brief Title
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Official Title
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D plus Calcium (Ca) supplementation
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D2 (Ergocalciferol)
Intervention Description
50,000IU (or 1 tablet), PO, monthly (supplements to be taken for three months)
Intervention Type
Drug
Intervention Name(s)
Medroxyprogesterone (Provera)
Intervention Description
10mg, PO, daily for ten days
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3 (Cholecalciferol)
Intervention Description
2,000IU (or 2 tablets), PO, daily (supplements taken for three months)
Intervention Type
Dietary Supplement
Intervention Name(s)
Elemental Calcium
Intervention Description
1,000mg (or 2 tablets), PO, daily (supplements taken for three months)
Primary Outcome Measure Information:
Title
Serum HbA1C at 3 Months
Description
Fasting HbA1C levels at study completion after 3 month treatment
Time Frame
Completion
Title
Fasting Insulin Levels at Study Completion After 3 Month Treatment
Description
Fasting insulin levels at study completion after 3 month treatment
Time Frame
3 months intervention
Title
Fasting Glucose Levels at Completion of Treatment, at 3 Months
Description
Fasting glucose levels drawn after 3 months completion during oral GTT
Time Frame
3 months
Title
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
Description
Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT
Time Frame
3 months
Title
AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months
Description
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 Outcome Measure Information:
Title
Serum Levels of C-reactive Protein at Completion of 3 Months Treatment
Description
Serum levels of C-reactive protein upon completion, at 3 months
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lubna Pal, MBBS,MRCOG,MSc.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital-Women's Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8063
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22780885
Citation
Pal L, Berry A, Coraluzzi L, Kustan E, Danton C, Shaw J, Taylor H. Therapeutic implications of vitamin D and calcium in overweight women with polycystic ovary syndrome. Gynecol Endocrinol. 2012 Dec;28(12):965-8. doi: 10.3109/09513590.2012.696753. Epub 2012 Jul 11.
Results Reference
result
PubMed Identifier
22981957
Citation
Nardell M, Chhabra A, Pal L. Excluded, not dismissed: enhancing benefit in clinical research. Contemp Clin Trials. 2013 Jan;34(1):70-3. doi: 10.1016/j.cct.2012.08.013. Epub 2012 Sep 7.
Results Reference
derived

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

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