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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
105
400 IU daily (low dose)
2000 IU daily (high dose)
University of Miami
Miami, Florida, United States
Number of Participants Who Develop Hypercalcemia
calcium serum levels measured at baseline and at the end of the intervention (6-months)
Time frame: 6 months
Change From Baseline in Serum 25-hydroxyvitamin D Levels
Time frame: baseline and 6 months
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