Safety of Vitamin D Supplementation in Older Persons
Phase 3
Completed
- Conditions
- Vitamin D Deficiency
- Registration Number
- NCT00681590
- Lead Sponsor
- University of Miami
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
Inclusion Criteria
- ambulatory
Exclusion Criteria
- hypercalcemia
- hypercalciuria > 4 mg/kg body weight/day
- primary, secondary, or tertiary hyperparathyroidism
- renal insufficiency (serum creatinine > 2 mg/dL )
- history of nephrolithiasis
- treatment with vitamin D (ergocalciferol, cholecalciferol, calcitriol)
- treatment with anticonvulsants
- Paget's disease
- severe cardiac, pulmonary, hepatic, renal, or neurological disease
- life expectancy < 1 year
- participation in another trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of Participants Who Develop Hypercalcemia 6 months calcium serum levels measured at baseline and at the end of the intervention (6-months)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Serum 25-hydroxyvitamin D Levels baseline and 6 months
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States
University of Miami🇺🇸Miami, Florida, United States