TY  - JOUR
PY  - 2018//
TI  - Rationale and design of the Study to Understand Fall Reduction and vitamin D in You (STURDY): a randomized clinical trial of vitamin D supplement doses for the prevention of falls in older adults
JO  - Contemporary clinical trials
A1  - Michos, Erin D.
A1  - Mitchell, Christine M.
A1  - Miller, Edgar R.
A1  - Sternberg, Alice L.
A1  - Juraschek, Stephen P.
A1  - Schrack, Jennifer A.
A1  - Szanton, Sarah L.
A1  - Walston, Jeremy D.
A1  - Kalyani, Rita R.
A1  - Plante, Timothy B.
A1  - Christenson, Robert H.
A1  - Shade, Dave
A1  - Tonascia, James
A1  - Roth, David L.
A1  - Appel, Lawrence J.
A1  - Appel, Lawrence J.
A1  - Cronin, Nicole
A1  - Juraschek, Stephen P.
A1  - McClure, Scott
A1  - Mitchell, Christine M.
A1  - Plante, Timothy B.
A1  - Kalyani, Rita R.
A1  - Roth, David L.
A1  - Schrack, Jennifer A.
A1  - Szanton, Sarah L.
A1  - Urbanek, Jacek
A1  - Walston, Jeremy
A1  - Baksh, Sheriza
A1  - Blackford, Amanda L.
A1  - Chattopadhyay, Shumon
A1  - Dodge, John
A1  - Ewing, Cathleen
A1  - Jackson, Rosetta
A1  - Lears, Andrea
A1  - Meinert, Curtis
A1  - Shade, David
A1  - Smith, Michael
A1  - Sternberg, Alice L.
A1  - Tonascia, James
A1  - Van Natta, Mark L.
A1  - Wagoner, Annette
A1  - Michos, Erin D.
A1  - Bowers, Pamela
A1  - Coresh, Josef
A1  - Crunkleton, Tammy
A1  - Dick, Briana
A1  - Evans, Rebecca
A1  - Godwin, Mary
A1  - Hammann, Lynne
A1  - Hawks, Deborah
A1  - Horning, Karen
A1  - Minotti, Melissa
A1  - Myers, Melissa
A1  - Raley, Leann
A1  - Reid, Cassie
A1  - Spikes, Adria
A1  - Stouffer, Rhonda
A1  - Weicht, Kelly
A1  - Miller, Edgar R.
A1  - Carey, Bernellyn
A1  - Charleston, Jeanne
A1  - DeRoche-Brown, Naomi
A1  - Gayles, Debra
A1  - Glenn-Smith, Ina
A1  - Johnson, Duane
A1  - Johnson, Mia
A1  - Keyes, Eva
A1  - McArthur, Kristen
A1  - Santiago, Danielle
A1  - Sapun, Chanchai
A1  - Sneed, Valerie
A1  - Thomas, Letitia
A1  - Christenson, Robert H.
A1  - Duh, Show-Hong
A1  - Rebuck, Heather
A1  - Rosen, Clifford J.
A1  - Cook, Tom
A1  - Duncan, Pamela
A1  - Hansen, Karen
A1  - Kenny, Anne
A1  - Shapses, Sue
A1  - Hannah, Judy
A1  - Romashkan, Sergei
A1  - Davis, Cindy D.
A1  - Guralnik, Jack M.
A1  - Gallagher, J. C.
SP  - 111
EP  - 122
VL  - 73
IS  - 
N2  - Prior evidence suggests that vitamin D supplementation may reduce fall risk, but existing data are inconsistent and insufficient to guide policy. We designed a two-stage Bayesian response-adaptive dose-finding and seamless confirmatory randomized trial of vitamin D supplementation to prevent falls. Up to 1200 community-dwelling persons, aged ≥70 years, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29 ng/mL and at elevated fall risk, will be randomized to one of four vitamin D3 (cholecalciferol) supplement doses: 200 (control), 1000, 2000, or 4000 IU/day and treated for up to 2 years. Stage 1 is designed to identify the best of the non-control doses for fall prevention. If a best dose is selected, Stage 2 will start seamlessly, with enrollees assigned to control or the best dose in Stage 1 continuing on that dose unchanged, enrollees assigned to the two non-control, non-best doses in Stage 1 switched to the best dose, and new enrollees randomly assigned 1:1 to control or the best dose. In Stage 2, we will compare the control dose group to the best dose group to potentially confirm the efficacy of that dose for fall prevention. The primary outcome measure in both stages is time to first fall or death, whichever comes first. Falls are ascertained from calendars, scheduled interviews, or interim self-reports. Secondary outcome measures include time to each component of the composite primary outcome and gait speed. Additional outcomes include the Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score. CLINICAL TRIAL REGISTRATION: NCT02166333.<br><br>Copyright © 2018. Published by Elsevier Inc.<p />  <p>Language: en</p>
LA  - en
SN  - 1551-7144
UR  - http://dx.doi.org/10.1016/j.cct.2018.08.004
ID  - ref1
ER  -