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

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ClinicalTrials.gov Identifier: NCT00743574
Recruitment Status : Completed
First Posted : August 29, 2008
Results First Posted : July 29, 2013
Last Update Posted : July 29, 2013
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Lubna Pal, 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).

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Vitamin D Deficiency Dietary Supplement: Vitamin D2 (Ergocalciferol) Drug: Medroxyprogesterone (Provera) Dietary Supplement: Vitamin D3 (Cholecalciferol) Dietary Supplement: Elemental Calcium Not Applicable

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  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
Study Start Date : August 2008
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



Primary Outcome Measures :
  1. Participants Were Assessed at Study Completion After 3 Month Treatment [ 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 Outcome Measures :
  1. Serum Levels of C-reactive Protein at Completion of 3 Months Treatment Compared to Baseline. [ Time Frame: 3 months ]
    Serum levels of C-reactive protein upon completion, at 3 months



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743574


Locations
United States, Connecticut
Yale-New Haven Hospital-Women's Center
New Haven, Connecticut, United States, 06520-8063
Sponsors and Collaborators
Yale University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Lubna Pal, MBBS,MRCOG,MSc. Yale University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lubna Pal, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00743574     History of Changes
Other Study ID Numbers: YaleU-0807003992
YCCI-CARE Grant #UL1RR024139
First Posted: August 29, 2008    Key Record Dates
Results First Posted: July 29, 2013
Last Update Posted: July 29, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Syndrome
Vitamin D Deficiency
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Calcium, Dietary
Medroxyprogesterone
Medroxyprogesterone Acetate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral