The Relationship of Falls With Achieved 25-Hydroxyvitamin D Levels From Vitamin D Supplementation: The STURDY Trial

Erin D Michos, Rita R Kalyani, Amanda L Blackford, Alice L Sternberg, Christine M Mitchell, Stephen P Juraschek, Jennifer A Schrack, Amal A Wanigatunga, David L Roth, Robert H Christenson, Edgar R Miller 3rd, Lawrence J Appel, Erin D Michos, Rita R Kalyani, Amanda L Blackford, Alice L Sternberg, Christine M Mitchell, Stephen P Juraschek, Jennifer A Schrack, Amal A Wanigatunga, David L Roth, Robert H Christenson, Edgar R Miller 3rd, Lawrence J Appel

Abstract

Context: The Study to Understand Fall Reduction and Vitamin D in You (STURDY), a randomized trial enrolling older adults with low 25-hydroxyvitamin D [25(OH)D], demonstrated vitamin D supplementation ≥ 1000 IU/day did not prevent falls compared with 200 IU/day, with doses ≥ 2000 IU/day potentially showing safety concerns.

Objective: To examine associations of achieved and change in 25(OH)D concentrations after 3 months of vitamin D supplementation with fall risk.

Design: Observational analysis of trial data.

Setting: General community.

Participants: A total of 637 adults aged ≥ 70 with baseline 25(OH)D concentrations 10 to 29 ng/mL and elevated fall risk. Three-month on-treatment absolute 25(OH)D; absolute and relative changes from baseline.

Main outcome measures: Incident first fall (primary) and first consequential fall (injury or sought medical care) up to 24 months. Cox models were adjusted for sociodemographics, season, Short Physical Performance Battery, and body mass index.

Results: At baseline, mean (SD) age was 77.1 (5.4) years and 25(OH)D was 22.1 (5.1) ng/mL; 43.0% were women and 21.5% non-White. A total of 395 participants experienced ≥ 1 fall; 294 experienced ≥ 1 consequential fall. There was no association between absolute achieved 25(OH)D and incident first fall (30-39 vs < 30 ng/mL hazard ratio [HR], 0.93; 95% CI, 0.74-1.16; ≥40 vs < 30 ng/mL HR, 1.09; 95% CI, 0.82-1.46; adjusted overall P = 0.67), nor absolute or relative change in 25(OH)D. For incident consequential first fall, the HR (95% CI) comparing absolute 25(OH)D ≥ 40 vs < 30 ng/mL was 1.38 (0.99-1.90).

Conclusion: Achieved 25(OH)D concentration after supplementation was not associated with reduction in falls. Risk of consequential falls may be increased with achieved concentrations ≥ 40 ng/mL.

Trial registration: ClinicalTrials.gov: NCT02166333.

Keywords: 25-hydroxvitamin D; fall risk; vitamin D.

© The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society.

Figures

Figure 1.
Figure 1.
Serum 25(OH)D concentration over time. Box plots of serum 25(OH)D concentration (ng/mL) before random assignment to vitamin D supplementation of 200, 1000, 2000, or 4000 IU/day and 3, 12, and 24 months later. To convert 25(OH)D ng/mL to nmol/L, multiply ng/mL by 2.5.
Figure 2.
Figure 2.
Change in serum 25(OH)D concentration after 3 months of vitamin D supplementation. (A) Histogram of absolute change in serum 25(OH)D concentration in 637 participants 3 months after randomization to the vitamin D study pill (dose 200, 1000, 2000, or 4000 IU/day). Absolute change in serum 25(OH)D was calculated as concentration at 3 months minus concentration at baseline. Changes were sorted into bins of width 5 ng/mL. To convert 25(OH)D ng/ml to nmol/L multiply the ng/ml by 2.5. (B) Histogram of relative (%) change in serum 25(OH)D in 637 participants 3 months after randomization to the vitamin D study pill (dose 200, 1000, 2000, or 4000 IU/day). Relative change in serum 25(OH)D was calculated as (concentration at 3 months minus concentration at baseline) divided by concentration at baseline. Fifty-eight participants had a percent decrease (3% to 36%), 27 participants had no change, and 552 participants had a percent increase in serum 25(OH)D at 3 months relative to baseline. The x-axis uses a log scale.

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