Vitamin D in Vulnerable Adults (VIVA-VA)
VIVA-VA
1 other identifier
interventional
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2010
CompletedFirst Posted
Study publicly available on registry
July 27, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
December 21, 2016
CompletedDecember 21, 2016
October 1, 2016
3.8 years
July 22, 2010
May 17, 2016
October 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline and 9 months
Study Arms (2)
Placebo Arm
PLACEBO COMPARATORplacebo capsule
Cholecalciferol 4000 IU
EXPERIMENTALcholecalciferol 4000 IU daily
Interventions
Eligibility Criteria
You may qualify if:
- male veterans
- to 95 years of age
- independent
- sedentary
- vitamin D insufficiency
You may not qualify if:
- hypercalcemia
- renal failure
- living in a nursing home
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Medical Center, Miami
Miami, Florida, 33125, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Silvina Levis MD
- Organization
- Miami VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Silvina Levis-Dusseau, MD
VA Medical Center, Miami
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2010
First Posted
July 27, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
December 21, 2016
Results First Posted
December 21, 2016
Record last verified: 2016-10