Safety of Vitamin D Supplementation in Older Persons



Status:Completed
Conditions:Other Indications, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:65 - 95
Updated:4/21/2016
Start Date:April 2008
End Date:April 2009

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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.

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.

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
We found this trial at
1
site
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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Miami, FL
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