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Sponsors and Collaborators: |
Washington University School of Medicine AstraZeneca |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00263185 |
The purpose of this study is to determine whether Vitamin D supplementation reduces the symptoms of muscle stiffness and joint tenderness that some patients may develop after starting therapy with Anastrozole for breast cancer.
Condition | Intervention |
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Breast Neoplasms |
Drug: Vitamin D Drug: Calcium carbonate Other: Vitamin D |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Trial of High Dose Vitamin D Therapy On Musculoskeletal Symptoms and Bone Mineral Density in Anastrozole-Treated Early Stage Breast Cancer Patients With Marginal Vitamin D Status |
Estimated Enrollment: | 60 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Active Treatment
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Drug: Vitamin D
Vitamin D 400 U/day for 8 weeks
Drug: Calcium carbonate
Calcium carbonate 1000 mg/day for 8 weeks
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2: Placebo Comparator
Placebo control
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Drug: Calcium carbonate
Calcium carbonate 1000 mg/day fo 8 weeks
Drug: Vitamin D
Vitamin D 400 U/Day for 8 weeks
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3: No Intervention
Observation
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Other: Vitamin D
Vitamin D 50,000 IU for 16 weeks
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This is a pilot, double-blind, randomized, placebo-controlled study with the following aims:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: Shohreh Jamalabadi-Majidi | 314-362-2529 | sjamalab@dom.wustl.edu |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Antonella Rastelli, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University ( Antonella Rastelli, M.D. ) |
Study ID Numbers: | 05-0498 |
Study First Received: | December 6, 2005 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00263185 |
Health Authority: | United States: Institutional Review Board |
Calcium, Dietary Anastrozole Vitamin D Skin Diseases |
Ergocalciferols Breast Neoplasms Calcium Carbonate Breast Diseases |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bone Density Conservation Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Vitamins Therapeutic Uses Antacids Micronutrients Aromatase Inhibitors |