Vitamin D in Vulnerable Adults (VIVA-VA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01170273
First received: July 22, 2010
Last updated: August 12, 2014
Last verified: August 2014

July 22, 2010
August 12, 2014
August 2010
June 2014   (final data collection date for primary outcome measure)
change in lower extremity physical performance from baseline to 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01170273 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
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: Arm 1
    placebo capsule
    Intervention: Dietary Supplement: placebo
  • Experimental: Arm 2
    cholecalciferol 4000 IU daily
    Intervention: Dietary Supplement: vitamin D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
146
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
Male
65 Years to 95 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01170273
F7574-R
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Silvina Levis-Dusseau, MD VA Medical Center, Miami
Department of Veterans Affairs
August 2014

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