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

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ClinicalTrials.gov Identifier: NCT01170273
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : December 21, 2016
Last Update Posted : December 21, 2016
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Frail Elderly Vitamin d Deficiency Dietary Supplement: vitamin D Dietary Supplement: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D in Vulnerable Adults
Study Start Date : August 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Arm
placebo capsule
Dietary Supplement: placebo
placebo tablet
Experimental: Cholecalciferol 4000 IU
cholecalciferol 4000 IU daily
Dietary Supplement: vitamin D
cholecalciferol



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170273


Locations
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Silvina Levis-Dusseau, MD VA Medical Center, Miami

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01170273     History of Changes
Other Study ID Numbers: F7574-R
First Posted: July 27, 2010    Key Record Dates
Results First Posted: December 21, 2016
Last Update Posted: December 21, 2016
Last Verified: October 2016

Keywords provided by VA Office of Research and Development:
aged
vitamin d deficiency

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents