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

August 11, 2021 updated by: Yale University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8063
        • Yale-New Haven Hospital-Women's Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum HbA1C at 3 Months
Time Frame: Completion
Fasting HbA1C levels at study completion after 3 month treatment
Completion
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 months intervention
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
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
Time Frame: 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
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Center for Research Resources (NCRR)

Investigators

  • Principal Investigator: Lubna Pal, MBBS,MRCOG,MSc., Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

February 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (ESTIMATE)

August 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YaleU-0807003992
  • YCCI-CARE Grant #UL1RR024139

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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