The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults A Response-Adaptive, Randomized Clinical Trial

被引：58
作者：
Appel, Lawrence J. [1 ,9 ]
Michos, Erin D. [2 ,10 ]
Mitchell, Christine M. [3 ,11 ]
Blackford, Amanda L. [2 ,12 ]
Sternberg, Alice L. [3 ,13 ]
Miller, Edgar R., III [1 ,9 ,14 ]
Juraschek, Stephen P. [4 ,5 ,15 ]
Schrack, Jennifer A. [3 ,16 ]
Szanton, Sarah L. [6 ,17 ]
Charleston, Jeanne [3 ,18 ]
Minotti, Melissa [3 ,19 ]
Baksh, Sheriza N. [3 ,20 ]
Christenson, Robert H. [7 ]
Coresh, Josef [3 ,21 ]
Drye, Lea T. [3 ,22 ]
Guralnik, Jack M. [7 ,23 ]
Kalyani, Rita R. [2 ,24 ]
Plante, Timothy B. [8 ,25 ]
Shade, David M. [3 ,26 ]
Roth, David L. [1 ,9 ,27 ]
Tonascia, James [3 ,13 ]
机构：
[1] Johns Hopkins Univ, Baltimore, MD USA
[2] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[3] Johns Hopkins Bloomberg Sch Publ Hlth, Baltimore, MD USA
[4] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
[5] Harvard Med Sch, Boston, MA 02115 USA
[6] Johns Hopkins Univ, Sch Nursing, Baltimore, MD USA
[7] Univ Maryland, Sch Med, 655 West Baltimore St South,Room N2W70C, Baltimore, MD 21201 USA
[8] Univ Vermont, Larner Coll Med, Burlington, VT USA
[9] Welch Ctr Prevent Epidemiol & Clin Res, 2024 East Monument St,Room 2-642, Baltimore, MD 21287 USA
[10] Johns Hopkins Univ Hosp, Blalock 524-B,600 North Wolfe St, Baltimore, MD 21287 USA
[11] Welch Ctr Prevent Epidemiol & Clin Res, 2024 East Monument St,Room 2-507, Baltimore, MD 21287 USA
[12] 550 North Broadway,Room 1111, Baltimore, MD 21205 USA
[13] 615 North Wolfe St,Room W5025, Baltimore, MD 21205 USA
[14] Welch Ctr Prevent Epidemiol & Clin Res, 2024 East Monument St,Room 1-500M, Baltimore, MD 21287 USA
[15] Beth Israel Deaconess Med Ctr, Div Gen Med, Sect Res, 330 Brookline Ave,CO-1309,216, Boston, MA 02215 USA
[16] 615 North Wolfe St,E7144, Baltimore, MD 21205 USA
[17] Sch Nursing, 525 North Wolfe St,Suite 424, Baltimore, MD 21205 USA
[18] Dept Epidemiol, 1849 Gwynn Oak Ave, Baltimore, MD 21207 USA
[19] George W Comstock Ctr Publ Hlth Res & Prevent, 1100 Dual Highway, Hagerstown, MD 21740 USA
[20] 415 North Washington St,Room 209, Baltimore, MD 21231 USA
[21] Welch Ctr Prevent Epidemiol & Clin Res, 2024 East Monument St,Room 2-631, Baltimore, MD 21287 USA
[22] 2789 Parkers Landing Rd, Mt Pleasant, SC 29466 USA
[23] Univ Maryland, Sch Epidemiol, 660 West Redwood St,Room 200, Baltimore, MD 21201 USA
[24] Johns Hopkins Sch Med, Div Endocrinol Diabet & Metab, 1830 East Monument St,Room 333, Baltimore, MD 21205 USA
[25] 360 South Pk Dr,Suite 206, Colchester, VT 05446 USA
[26] 415 North Washington St,Room 231, Baltimore, MD 21231 USA
[27] Ctr Aging, 2024 East Monument St,Room 2-700, Baltimore, MD 21287 USA
来源：
ANNALS OF INTERNAL MEDICINE | 2021年 / 174卷 / 02期
关键词：
D DEFICIENCY; PREVENTION; WOMEN; RISK; RESIDENTS; STRENGTH; CALCIUM;
D O I：
10.7326/M20-3812
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
Background: Vitamin D supplementation may prevent falls in older persons, but evidence is inconsistent, possibly because of dosage differences. Objective: To compare the effects of 4 doses of vitamin D-3 supplements on falls. Design: 2-stage Bayesian, response-adaptive, randomized trial. Setting: 2 community-based research units. Participants: 688 participants, aged 70 years and older, with elevated fall risk and a serum 25-hydroxyvitamin D [25-(OH)D] level of 25 to 72.5 nmol/L. Intervention: 200 (control), 1000, 2000, or 4000 IU of vitamin D-3 per day. During the dose-finding stage, participants were randomly assigned to 1 of the 4 vitamin D-3 doses, and the best noncontrol dose for preventing falls was determined. After dose finding, participants previously assigned to receive noncontrol doses received the best dose, and new enrollees were randomly assigned to receive 200 IU/d or the best dose. Measurements: Time to first fall or death over 2 years (primary outcome). Results: During the dose-finding stage, the primary outcome rates were higher for the 2000- and 4000-IU/d doses than for the 1000-IU/d dose, which was selected as the best dose (posterior probability of being best, 0.90). In the confirmatory stage, event rates were not significantly different between participants with experience receiving the best dose (events and observation time limited to the period they were receiving 1000 IU/d; n = 308) and those randomly assigned to receive 200 IU/d (n = 339) (hazard ratio [HR], 0.94 [95% CI, 0.76 to 1.15]; P = 0.54). Analysis of falls with adverse outcomes suggested greater risk in the experience-with-best-dose group versus the 200-IU/d group (serious fall: HR, 1.87 [CI, 1.03 to 3.41]; fall with hospitalization: HR, 2.48 [CI, 1.13 to 5.46]). Limitations: The control group received 200 IU of vitamin D-3 per day, not a placebo. Dose finding ended before the prespecified thresholds for dose suspension and dose selection were reached. Conclusion: In older persons with elevated fall risk and low serum 25-(OH)D levels, vitamin D-3 supplementation at doses of 1000 IU/d or higher did not prevent falls compared with 200 IU/d. Several analyses raised safety concerns about vitamin D-3 doses of 1000 IU/d or higher.
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页码：145 / +
页数：13
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