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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170273
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

July 22, 2010
July 27, 2010
May 17, 2016
December 21, 2016
December 21, 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 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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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Frail Elderly
  • Vitamin d Deficiency
  • Dietary Supplement: vitamin D
  • 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 Identifier (NCT Number) in Medline.
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)
Contact information is only displayed when the study is recruiting subjects
United States
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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