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Sponsors and Collaborators: |
University of Miami Merck |
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Information provided by: | University of Miami |
ClinicalTrials.gov Identifier: | NCT00681590 |
This study will evaluate the safety over 6 months of two different doses of vitamin D (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation with vitamin D improves physical performance.
Condition | Intervention | Phase |
---|---|---|
Vitamin D Deficiency |
Dietary Supplement: cholecalciferol (vitamin D) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety of Vitamin D Supplementation in the Elderly |
Estimated Enrollment: | 120 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
vitamin D (cholecalciferol) 400 IU
|
Dietary Supplement: cholecalciferol (vitamin D)
400 IU daily
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2: Active Comparator
vitamin D (cholecalciferol) 2000 IU
|
Dietary Supplement: cholecalciferol (vitamin D)
2000 IU daily
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120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will participate in the clinical trial for 6 months.
Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically. Physical performance will be tested at baseline and throughout the study.
Ages Eligible for Study: | 65 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Luis Rochel, RN | 305 243-4012 | Lrochel@med.miami.edu |
Contact: Silvina Levis, MD | 305 243-4330 | slevis@med.miami.edu |
United States, Florida | |
University of Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Luis Rochel, RN 305-243-4012 lrochel@med.miami.edu | |
Contact: Silvina Levis, MD 305 243-4330 slevis@med.miami.edu |
Principal Investigator: | Silvina Levis, MD | University of Miami |
Responsible Party: | University of Miami ( Silvina Levis, MD ) |
Study ID Numbers: | 20070018 |
Study First Received: | May 15, 2008 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00681590 |
Health Authority: | United States: Institutional Review Board |
vitamin D deficiency elderly |
Vitamin D Deficiency Cholecalciferol Vitamin D Malnutrition |
Avitaminosis Ergocalciferols Nutrition Disorders Deficiency Diseases |
Growth Substances Vitamins Physiological Effects of Drugs |
Bone Density Conservation Agents Micronutrients Pharmacologic Actions |