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Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
This study is currently recruiting participants.
Verified by Yale University, August 2008
Sponsors and Collaborators: Yale University
National Center for Research Resources (NCRR)
Information provided by: Yale University
ClinicalTrials.gov Identifier: NCT00743574
  Purpose

The investigators aim is to conduct a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation use in overweight (BMI > 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and have Vitamin D insufficiency, as reflected by serum 25-hydroxyl (25-OH) Vitamin D (serum levels < 20 ng/mL).


Condition Intervention
Polycystic Ovarian Syndrome
Vitamin D Deficiency
Dietary Supplement: Vitamin D2 (Ergocalciferol)
Drug: Medroxyprogesterone (Provera)
Dietary Supplement: Vitamin D3 (Cholecalciferol)
Dietary Supplement: Elemental Calcium

MedlinePlus related topics: Calcium Dietary Supplements
Drug Information available for: Calcium gluconate Vitamin D Ergocalciferol Cholecalciferol Medroxyprogesterone Medroxyprogesterone 17-acetate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Improve the glycemic profile as demonstrated by levels of HbA1c, fasting insulin/glucose, and the area under the curve for insulin and glucose obtained during a two-hour oral glucose tolerance test (OGTT) compared to baseline. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Result in an improvement in the pro-inflammatory milieu that is characteristic of PCOS, i.e. a reduction in serum levels of c-reactive protein compared to baseline. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: August 2008
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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)
Detailed Description:

We hypothesize that administering optimal daily doses of Vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of Ca, both per oral (PO), over a three month period in women with PCOS will yield significant results in the improvement of their condition.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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-alphahydroxylprogesterone 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00743574

Contacts
Contact: Lubna Pal, MBBS, MRCOG, MSc. (203) 785-4016 lubna.pal@yale.edu
Contact: Luisa Coraluzzi, BSN, RN (203) 785-2164 luisa.coraluzzi@yale.edu

Locations
United States, Connecticut
Yale-New Haven Hospital-Women's Center Recruiting
New Haven, Connecticut, United States, 06520-8063
Contact: Luisa Coraluzzi, BSN, RN     (203) 785-2164     luisa.coraluzzi@yale.edu    
Contact: Amber Berry, BA     (203) 785-7403     amber.berry@yale.edu    
Principal Investigator: Lubna Pal, MBBS, MRCOG, MSc.            
Sub-Investigator: Julia Shaw, MD            
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Lubna Pal, MBBS,MRCOG,MSc. Yale University
  More Information

Responsible Party: Yale University School of Medicine ( Lubna Pal, MBBS, MRCOG, MSc./Assistant Professor, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility )
Study ID Numbers: YaleU-0807003992, YCCI-CARE Grant #UL1RR024139
Study First Received: August 28, 2008
Last Updated: August 29, 2008
ClinicalTrials.gov Identifier: NCT00743574  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Vitamin D Deficiency
Cholecalciferol
Medroxyprogesterone 17-Acetate
Gonadal Disorders
Avitaminosis
Ergocalciferols
Endocrine System Diseases
Ovarian Diseases
Cysts
Genital Diseases, Female
Calcium, Dietary
Vitamin D
Malnutrition
Polycystic Ovary Syndrome
Nutrition Disorders
Medroxyprogesterone
Endocrinopathy
Ovarian Cysts
Deficiency Diseases

Additional relevant MeSH terms:
Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Contraceptive Agents
Growth Substances
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Bone Density Conservation Agents
Reproductive Control Agents
Contraceptive Agents, Male
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Vitamins
Contraceptives, Oral, Synthetic
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009