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Vitamin D in Vulnerable Adults (VIVA-VA)

NCT ID: NCT01170273

Last Updated: 2016-12-21

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

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2014-12-31

Brief Summary

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Vitamin D insufficiency is a problem of growing concern, given its prevalence in older persons and the association of low vitamin D with multiple major health problems, including mobility and balance deterioration and falls, cardiovascular disease, diabetes, and certain cancers. Sedentary persons are particularly vulnerable for these health problems and generally not adherent to prescribed physical activity. This study will investigate if treatment with vitamin D will benefit physical performance in male veterans age 65 to 95.

Detailed Description

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Conditions

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Frail Elderly Vitamin d Deficiency

Keywords

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aged 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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Placebo Arm

placebo capsule

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

placebo tablet

Cholecalciferol 4000 IU

cholecalciferol 4000 IU daily

Group Type EXPERIMENTAL

vitamin D

Intervention Type DIETARY_SUPPLEMENT

cholecalciferol

Interventions

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vitamin D

cholecalciferol

Intervention Type DIETARY_SUPPLEMENT

placebo

placebo tablet

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* male veterans
* 65 to 95 years of age
* independent
* sedentary
* vitamin D insufficiency

Exclusion Criteria

* hypercalcemia
* renal failure
* living in a nursing home
Minimum Eligible Age

65 Years

Maximum Eligible Age

95 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvina Levis-Dusseau, MD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Miami

Locations

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VA Medical Center, Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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F7574-R

Identifier Type: -

Identifier Source: org_study_id