Status:
COMPLETED
Safety of Vitamin D Supplementation in Older Persons
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
65-95 years
Phase:
PHASE3
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 impro...
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 calc...
Eligibility Criteria
Inclusion
- ambulatory
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00681590
Start Date
April 1 2008
End Date
April 1 2009
Last Update
January 26 2017
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136