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

Erin D Michos^{1

2

3}, Rita R Kalyani^{3

4}, Amanda L Blackford⁵, Alice L Sternberg², Christine M Mitchell^{2

3}, Stephen P Juraschek⁶, Jennifer A Schrack^{2

7}, Amal A Wanigatunga^{2

7}, David L Roth^{7

8}, Robert H Christenson⁹, Edgar R Miller 3rd^{3

10}, Lawrence J Appel^{3

10}

Affiliations

¹ Division of Cardiology, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
² Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
³ Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD 21205, USA.
⁴ Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
⁵ Division of Biostatistics and Bioinformatics, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.
⁶ Division of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School Teaching Hospital, Boston, MA 02215, USA.
⁷ Center on Aging and Health, Johns Hopkins University and Medical Institutions, Baltimore, MD 21205, USA.
⁸ Division of Geriatric Medicine and Gerontology, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.
⁹ Department of Pathology, University of Maryland Medical Center, Baltimore, MD 21201, USA.
¹⁰ Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.

PMID: 35592513
PMCID: PMC9113179
DOI: 10.1210/jendso/bvac065

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

Erin D Michos et al. J Endocr Soc. 2022.

. 2022 Apr 16;6(6):bvac065.

doi: 10.1210/jendso/bvac065. eCollection 2022 Jun 1.

Authors

Affiliations

¹ Division of Cardiology, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
² Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
³ Welch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University, Baltimore, MD 21205, USA.
⁴ Division of Endocrinology, Diabetes, and Metabolism, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.
⁵ Division of Biostatistics and Bioinformatics, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.
⁶ Division of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School Teaching Hospital, Boston, MA 02215, USA.
⁷ Center on Aging and Health, Johns Hopkins University and Medical Institutions, Baltimore, MD 21205, USA.
⁸ Division of Geriatric Medicine and Gerontology, Johns Hopkins School of Medicine, Baltimore, MD 21205, USA.
⁹ Department of Pathology, University of Maryland Medical Center, Baltimore, MD 21201, USA.
¹⁰ Division of General Internal Medicine, Johns Hopkins School of Medicine, Baltimore, MD 21287, USA.

PMID: 35592513
PMCID: PMC9113179
DOI: 10.1210/jendso/bvac065

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.

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Figures

**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.**
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.

See this image and copyright information in PMC

References

1. Grossman DC, Curry SJ, Owens DK; US Preventive Services Task Force. Interventions to Prevent Falls in Community-Dwelling Older Adults: US Preventive Services Task Force Recommendation Statement. JAMA 2018;319(16):1696-1704. doi:10.1001/jama.2018.3097. - DOI - PubMed
1. National Council on Aging. https://www.ncoa.org/article/get-the-facts-on-falls-prevention. Accessed November 28, 2020.
1. Holick MF. Vitamin D deficiency. N Engl J Med. 2007;357(3):266-281. doi:10.1056/NEJMra070553. - DOI - PubMed
1. Hannan MT, Litman HJ, Araujo AB, et al. . Serum 25-hydroxyvitamin D and bone mineral density in a racially and ethnically diverse group of men. J Clin Endocrinol Metab. 2008;93(1):40-46. - PMC - PubMed
1. Michos ED, Mitchell CM, Miller ER 3rd, et al. . 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. Contemp Clin Trials. 2018;73:111-122. - PMC - PubMed

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

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

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