Safety of Vitamin D Supplementation in the Elderly
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.
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.
Status: Recruiting (Phase 3). Started on April 1st, 2008.
Enrollment: 120 subjects
Study Type: Interventional
Study Design:
- Prevention
- Randomized
- Double Blind (Subject
- Caregiver
- Investigator
- Outcomes Assessor)
- Dose Comparison
- Parallel Assignment
- Safety/Efficacy Study
Conditions:
Interventions:
- Dietary Supplement: cholecalciferol (vitamin D)
- Dietary Supplement: cholecalciferol (vitamin D)
Eligibility
Inclusion Criteria:
- ambulatory
Exclusion Criteria:
hypercalcemia
hypercalciuria > 4 mg/kg body weight/day
primary, secondary, or tertiaryhyperparathyroidism
renal insufficiency (serum creatinine > 2 mg/dL )
history of nephrolithiasis
treatment with vitamin D (ergocalciferol, cholecalciferol, caltitriol)
treatment with anticonvulsants
Paget’s disease
severe cardiac, pulmonary, hepatic, renal, or neurological disease
life expectancy < 1 year
participation in another trial
- Gender
Both
- Mininum Age
65 Years
- Maximum Age
95 Years
- Healthy Volunteers
Accepts Healthy Volunteers
Resources
Source: University of Miami
Authority: United States: Institutional Review Board
Locations
-
University of Miami
Miami
Florida
33136
United States
Officials
Silvina Levis, MD (Principal Investigator, University of Miami)
Sponsors
University of Miami (Lead Sponsor)
Merck (Collaborator)
References
None.
Links
None.
- Date Verified
- May 1st, 2008
- First Received
- May 19th, 2008
- Last Changed
- May 19th, 2008
Information obtained from ClinicalTrials.gov on July 15, 2008. Link to the current ClinicalTrials.gov record.
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