@article{ref1,
title="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",
journal="Contemporary clinical trials",
year="2018",
author="Michos, Erin D. and Mitchell, Christine M. and Miller, Edgar R. and Sternberg, Alice L. and Juraschek, Stephen P. and Schrack, Jennifer A. and Szanton, Sarah L. and Walston, Jeremy D. and Kalyani, Rita R. and Plante, Timothy B. and Christenson, Robert H. and Shade, Dave and Tonascia, James and Roth, David L. and Appel, Lawrence J. and Appel, Lawrence J. and Cronin, Nicole and Juraschek, Stephen P. and McClure, Scott and Mitchell, Christine M. and Plante, Timothy B. and Kalyani, Rita R. and Roth, David L. and Schrack, Jennifer A. and Szanton, Sarah L. and Urbanek, Jacek and Walston, Jeremy and Baksh, Sheriza and Blackford, Amanda L. and Chattopadhyay, Shumon and Dodge, John and Ewing, Cathleen and Jackson, Rosetta and Lears, Andrea and Meinert, Curtis and Shade, David and Smith, Michael and Sternberg, Alice L. and Tonascia, James and Van Natta, Mark L. and Wagoner, Annette and Michos, Erin D. and Bowers, Pamela and Coresh, Josef and Crunkleton, Tammy and Dick, Briana and Evans, Rebecca and Godwin, Mary and Hammann, Lynne and Hawks, Deborah and Horning, Karen and Minotti, Melissa and Myers, Melissa and Raley, Leann and Reid, Cassie and Spikes, Adria and Stouffer, Rhonda and Weicht, Kelly and Miller, Edgar R. and Carey, Bernellyn and Charleston, Jeanne and DeRoche-Brown, Naomi and Gayles, Debra and Glenn-Smith, Ina and Johnson, Duane and Johnson, Mia and Keyes, Eva and McArthur, Kristen and Santiago, Danielle and Sapun, Chanchai and Sneed, Valerie and Thomas, Letitia and Christenson, Robert H. and Duh, Show-Hong and Rebuck, Heather and Rosen, Clifford J. and Cook, Tom and Duncan, Pamela and Hansen, Karen and Kenny, Anne and Shapses, Sue and Hannah, Judy and Romashkan, Sergei and Davis, Cindy D. and Guralnik, Jack M. and Gallagher, J. C.",
volume="73",
number="",
pages="111-122",
abstract="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>",
language="en",
issn="1551-7144",
doi="10.1016/j.cct.2018.08.004",
url="http://dx.doi.org/10.1016/j.cct.2018.08.004"
}