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Vitamin D in Vulnerable Adults (VIVA-VA) (VIVA-VA)

Primary Purpose

Frail Elderly, Vitamin d Deficiency

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
vitamin D
placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Frail Elderly focused on measuring aged, vitamin d deficiency

Eligibility Criteria

65 Years - 95 Years (Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • VA Medical Center, Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Arm

Cholecalciferol 4000 IU

Arm Description

placebo capsule

cholecalciferol 4000 IU daily

Outcomes

Primary Outcome Measures

Change in Short Physical Performance Battery Test Score
The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.

Secondary Outcome Measures

Full Information

First Posted
July 22, 2010
Last Updated
October 28, 2016
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01170273
Brief Title
Vitamin D in Vulnerable Adults (VIVA-VA)
Acronym
VIVA-VA
Official Title
Vitamin D in Vulnerable Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly, Vitamin d Deficiency
Keywords
aged, vitamin d deficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
placebo capsule
Arm Title
Cholecalciferol 4000 IU
Arm Type
Experimental
Arm Description
cholecalciferol 4000 IU daily
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
cholecalciferol
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo tablet
Primary Outcome Measure Information:
Title
Change in Short Physical Performance Battery Test Score
Description
The short physical performance battery (SPPB) examines 3 areas of lower extremity function: static balance test, gait speed test and getting in and out of a chair test. The total SPPB score is the sum of the scores of the 3 components and can range from 0 to 12, with 0 reflecting severe limitations and 12 minimal or no limitations. The ranges for each subscale are: balance (0-4), gait speed (0-4), sit-to-stand (0-4). In all the subscales, 0 reflects worse outcome and 4 best outcome.
Time Frame
baseline and 9 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvina Levis-Dusseau, MD
Organizational Affiliation
VA Medical Center, Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States

12. IPD Sharing Statement

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Vitamin D in Vulnerable Adults (VIVA-VA)

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