A 600-patient trial suggests increased vitamin D supplementation was not associated with a decreased risk of falls but could increase risk of severe falls and fall-related injuries.
Results from a new study by investigators at Johns Hopkins University is providing evidence that could debunk the notion that increased vitamin D supplementation might reduce falls in older patients.
A randomized trial with more than 600 patients from a pair of US medical centers, results from the study suggests increased vitamin D supplementation at doses of 1000 IU/d or greater provided no benefit on reducing fall risk in older patients and even suggested increased supplementation was associated with potential safety concerns.
“This trial has implications for patients, clinicians, and policymakers. The study found no beneficial effect on fall prevention from supplemental vitamin D at doses of 1000 IU/d or higher compared with 200 IU/d,” wrote study investigators. “This finding supports guidelines, including those of the 2018 US Preventive Services Task Force, which reversed its 2012 recommendation and now does not recommend vitamin D supplementation for fall prevention in older persons without osteoporosis or vitamin D deficiency.”
With a lack of consensus surrounding the use of vitamin D supplementation for reducing the risk of falls in older patients, Lawrence Appel, MD, MPH, and a team of colleagues designed their study as a 2-stage Bayesian, response-adaptive, randomized trial at medical centers in Maryland. Investigators designed their study to include community-dwelling adults aged 70 years and older considered to be at elevated fall risk and with low serum 25-hydroxyvitamin D [25-(OH)D] levels.
Patients were considered to be at elevated fall risk if they reported having 2 or more falls or at least 1 injurious fall in the past year, reported a fear of falling due to balance or walking problems, reported difficulty maintaining balance, or reported use of an assistive device when walking. Patients included in the trial, completed 2 in-person visits followed by a 10-day run-in period. After this run-in period, patients became eligible for randomization and were randomized to receive 1 of 4 doses: 200 IU/d (control), 1000 IU/d, 2000 IU/d, or 4000 IU/d.
After randomization, investigators used fall data to determine the best noncontrol dose for preventing falls. After dose-finding, participants that were receiving a noncontrol dose were assigned to the best noncontrol dose and new enrollees were randomly assigned to 200 IU/d or the best noncontrol dose. The primary outcome of the trial was time to first fall or death over a 2-year study period.
A total of 688 participants were rolled in the study. The mean age at study entry was 77.2 (SD, 5.4) years, 56.4% of participants were men, 18.2% were Black, and the mean total 25-(OH)D level was 55.3 nmol/L. Of the 667 participants who completed the trial, the median follow-up time was 22 months. During the follow-up period, 433 participants experienced a primary outcome event (423 falls, 10 deaths) and 234 completed the trial without a primary outcome event.
After the dose-finding stage of the trial, investigators determined rates of the primary outcome were greater were higher for the 2000 and 4000 IU/d doses compared to the 1000 IU/d dose, which was selected as the best noncontrol dose. In the latter stages of the trial, event rates were not significantly different among those receiving the best dose and those randomly assigned to receive 200 IU/d (HR, 0.94; 95% CI, 0.76-1.15; P=.54). Further analysis suggested patients receiving the 1000 IU/d dose were at a greater risk of experiencing a serious fall (HR, 1.87; 95% CI, 1.03-3.41) or a fall requiring hospitalization (HR, 2.48; 95% CI, 1.13-5.46) than those receiving 200 IU/d.
In a related editorial, Bruce R. Troen, MD, of the University at Buffalo Jacobs School of Medicine, noted the valuable information provided by this trial but also pointed out the need for further research into the effects of vitamin D supplementation in older patients and on fall risk specifically.
“We still need additional creative clinical trials using interdisciplinary strategies to oppose the major burden that falls place on older adults and the health care system and better strive to enhance functional capacity, healthspan, and quality of life,” wrote Troen.
This study, “The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults,” was published in the Annals of Internal Medicine.