Vitamin D in Vulnerable Adults
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Change in Short Physical Performance Battery Test Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to 95 Years (Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo Arm
placebo capsule
Intervention: placebo (Dietary Supplement)
Cholecalciferol 4000 IU
cholecalciferol 4000 IU daily
Intervention: vitamin D (Dietary Supplement)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported