Safety of Vitamin D Supplementation in Older Persons

Phase 3

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: cholecalciferol (vitamin D)

• 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.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-15
• Study First Submitted QC: 2008-05-19
• Study First Posted: 2008-05-21
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2016-02-05
• Results First Submitted QC: 2016-02-05
• Results First Posted: 2016-03-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-02
• Last Update Posted: 2017-01-26

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

Arm && Interventions

Group	Intervention	Description
2	cholecalciferol (vitamin D)	vitamin D (cholecalciferol) 2000 IU daily orally - high dose
1	cholecalciferol (vitamin D)	vitamin D (cholecalciferol) 400 IU daily orally - low dose

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