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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01170273
First received: July 22, 2010
Last updated: October 28, 2016
Last verified: October 2016

July 22, 2010
October 28, 2016
August 2010
June 2014   (Final data collection date for primary outcome measure)
Change in Short Physical Performance Battery Test Score [ Time Frame: baseline and 9 months ]
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.
change in lower extremity physical performance from baseline to 9 months [ Time Frame: baseline and 9 months ]
Complete list of historical versions of study NCT01170273 on ClinicalTrials.gov Archive Site
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Vitamin D in Vulnerable Adults (VIVA-VA)
Vitamin D in Vulnerable Adults
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.
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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Frail Elderly
  • Vitamin d Deficiency
  • Dietary Supplement: vitamin D
    cholecalciferol
  • Dietary Supplement: placebo
    placebo tablet
  • Placebo Comparator: Placebo Arm
    placebo capsule
    Intervention: Dietary Supplement: placebo
  • Experimental: Cholecalciferol 4000 IU
    cholecalciferol 4000 IU daily
    Intervention: Dietary Supplement: vitamin D
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
65 Years to 95 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01170273
F7574-R
No
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VA Office of Research and Development
VA Office of Research and Development
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Principal Investigator: Silvina Levis-Dusseau, MD VA Medical Center, Miami
VA Office of Research and Development
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP