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

Study Overview

• Status: Completed
• Conditions: Frail Elderly; Vitamin d Deficiency
• Intervention / Treatment: Dietary supplement: placebo; Dietary supplement: vitamin D

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33125
      • VA Medical Center, Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Short Physical Performance Battery Test Score	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.	baseline and 9 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Silvina Levis-Dusseau, MD, VA Medical Center, Miami

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 22, 2010
• First Submitted That Met QC Criteria: July 23, 2010
• First Posted (Estimate): July 27, 2010

Study Record Updates

• Last Update Posted (Estimate): December 21, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: aged; vitamin d deficiency
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: F7574-R