Study design and baseline characteristics of participants in the Vitamin D in Vulnerable Adults at the VA (the VIVA Study).

Hypovitaminosis D has been associated with age-related physical decline and an increased risk for falls. The objective of this study is to test whether supplementation with 4000IU of vitamin D(3) (vitD(3)) for 9 months will improve, or slow down the decline of the ability to perform physical tests which have been associated with the preservation of independence in sedentary older men. We describe the study design and the baseline characteristics of the 314 men screened in the VIVA-VA Study (Vitamin D In Vulnerable Adults in the VA), a 2-year, single-site, double-blind, placebo-controlled, randomized clinical trial that enrolled sedentary male veterans ages 65 to 95. The main inclusion criteria are 25-OH vitamin D (25-OHD) levels between 10 and 30 ng/ml, and a Short Performance Physical Battery (SPPB) score ≤ 9. The primary outcome of the study is the SPPB. Subjects were recruited from the Miami Veterans Medical Center clinics. The study recruited 314 male veterans of multiethnic backgrounds. The baseline characteristics observed from the 314 men screened in the VIVA-VA Study are consistent with what is expected in a cohort of elderly sedentary men: low physical performance scores, and low 25OHD levels despite living in South Florida. The results of this study that uses a high dose of vitamin D in a cohort of sedentary older men could provide an evidence-based indication for vitamin D supplementation to improve physical performance in this population.