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Vitamin D in Vulnerable Adults (VIVA-VA)

This study is currently recruiting participants.
Verified March 2013 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01170273
First received: July 22, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  Purpose

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 90.


Condition Intervention Phase
Frail Elderly
Vitamin d Deficiency
 Dietary Supplement: vitamin D
Dietary Supplement: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D in Vulnerable Adults

Resource links provided by NLM:

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • change in lower extremity physical performance from baseline to 9 months [ Time Frame: baseline and 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 146
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
placebo capsule
 Dietary Supplement: placebo
placebo tablet
Experimental: Arm 2
cholecalciferol 4000 IU daily
 Dietary Supplement: vitamin D
cholecalciferol

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male veterans
  • 65 to 90 years of age
  • independent
  • sedentary
  • vitamin D insufficiency

Exclusion Criteria:

  • hypercalcemia
  • renal failure
  • living in a nursing home
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170273

Contacts
Contact: Silvana Cobian (305) 575-7000 ext 6284 silvana.cobian@va.gov
Contact: Carlos Canales (305) 575-7000 ext 6230 carlos.canales@va.gov

Locations
United States, Florida
VA Medical Center, Miami Recruiting
Miami, Florida, United States, 33125
Contact: Silvina Levis-Dusseau, MD     305-575-7000 ext 3388     Silvina.Levis-Dusseau@va.gov    
Contact: Hermes J Florez, MD PhD MPH     (305) 575-3388     hermes.florez@va.gov    
Principal Investigator: Silvina Levis-Dusseau, MD            
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Silvina Levis-Dusseau, MD VA Medical Center, Miami
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01170273     History of Changes
Other Study ID Numbers: F7574-R
Study First Received: July 22, 2010
Last Updated: March 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
aged
vitamin d deficiency

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

ClinicalTrials.gov processed this record on May 22, 2013