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NCT00681590 Clinical Trial

Safety of Vitamin D Supplementation in Older Persons

Vitamin D Deficiency Clinical Trial

Official title:
Safety of Vitamin D Supplementation in the Elderly

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00681590
Other study ID # 20070018
Secondary ID
Status Completed
Phase Phase 3
First received May 15, 2008
Last updated February 5, 2016
Start date April 2008
Est. completion date April 2009

Study information
Verified date February 2016
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 105
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 95 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• cholecalciferol (vitamin D)
400 IU daily (low dose)
• cholecalciferol (vitamin D)
2000 IU daily (high dose)

Locations
Country Name City State
United States University of Miami Miami Florida

Sponsors (2)
Lead Sponsor Collaborator
University of Miami Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lagari V, Gómez-Marín O, Levis S. The role of vitamin D in improving physical performance in the elderly. J Bone Miner Res. 2013 Oct;28(10):2194-201. doi: 10.1002/jbmr.1949. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Who Develop Hypercalcemia 6 months Yes
Secondary Change From Baseline in Serum 25-hydroxyvitamin D Levels baseline and 6 months No
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