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Sponsors and Collaborators: |
Yale University National Center for Research Resources (NCRR) |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00743574 |
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 |
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Polycystic Ovarian Syndrome Vitamin D Deficiency |
Dietary Supplement: Vitamin D2 (Ergocalciferol) Drug: Medroxyprogesterone (Provera) Dietary Supplement: Vitamin D3 (Cholecalciferol) Dietary Supplement: Elemental Calcium |
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) |
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) |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
PCOS diagnosis based on Rotterdam criteria: presence of at least 2 of the following criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Lubna Pal, MBBS,MRCOG,MSc. | Yale University |
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 |
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 |
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 |