Safety of Vitamin D Supplementation in Older Persons

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

vitamin D (cholecalciferol) 400 IU daily orally - low dose

Group Type ACTIVE_COMPARATOR

cholecalciferol (vitamin D)

Intervention Type DIETARY_SUPPLEMENT

400 IU daily (low dose)

2

vitamin D (cholecalciferol) 2000 IU daily orally - high dose

Group Type ACTIVE_COMPARATOR

cholecalciferol (vitamin D)

Intervention Type DIETARY_SUPPLEMENT

2000 IU daily (high dose)

Interventions

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cholecalciferol (vitamin D)

400 IU daily (low dose)

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol (vitamin D)

2000 IU daily (high dose)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes