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Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review.
Nutrients 2018; 10(8)N

Abstract

Recent guidelines have advocated against the use of vitamin D supplementation as a means to prevent falls in older adults. However, meta-analyses of the available trials have reached divergent conclusions, and the key design features of these trials have not been well characterized. We conducted a systematic review of 30 randomized trials that reported the effects of vitamin D supplements on falls. Trials were identified by reviewing references of published meta-analyses and updated with a systematic PubMed search. We assessed three key design features: (1) recruitment of participants with vitamin D deficiency or insufficiency; (2) provision of daily oral vitamin D supplementation; and (3) utilization of highly sensitive at-event falls ascertainment. The trials enrolled a median of 337 (IQR: 170-1864) participants. Four (13.3%) trials restricted enrollment to those who were at least vitamin D insufficient, 18 (60.0%) included at least one arm providing daily supplementation, and 16 (53.3%) used at-event reporting. There was substantial heterogeneity between trials, and no single trial incorporated all three key design features. Rather than concluding that vitamin D is ineffective as a means to prevent falls, these findings suggest that existing trial evidence is insufficient to guide recommendations on the use of vitamin D supplements to prevent falls.

Authors+Show Affiliations

Johns Hopkins School of Medicine, Baltimore, MD 21287, USA. otang@jhmi.edu. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA. otang@jhmi.edu.Johns Hopkins School of Medicine, Baltimore, MD 21287, USA. sjurasch@bidmc.harvard.edu. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA. sjurasch@bidmc.harvard.edu. The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, MD 21287, USA. sjurasch@bidmc.harvard.edu. Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. sjurasch@bidmc.harvard.edu. Harvard Medical School, Boston, MA 02115, USA. sjurasch@bidmc.harvard.edu.Johns Hopkins School of Medicine, Baltimore, MD 21287, USA. lappel@jhmi.edu. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21287, USA. lappel@jhmi.edu. The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins University, Baltimore, MD 21287, USA. lappel@jhmi.edu. Beth Israel Deaconess Medical Center, Boston, MA 02215, USA. lappel@jhmi.edu. Harvard Medical School, Boston, MA 02115, USA. lappel@jhmi.edu.

Pub Type(s)

Journal Article
Review
Systematic Review

Language

eng

PubMed ID

30049963

Citation

Tang, Olive, et al. "Design Features of Randomized Clinical Trials of Vitamin D and Falls: a Systematic Review." Nutrients, vol. 10, no. 8, 2018.
Tang O, Juraschek SP, Appel LJ. Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review. Nutrients. 2018;10(8).
Tang, O., Juraschek, S. P., & Appel, L. J. (2018). Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review. Nutrients, 10(8), doi:10.3390/nu10080964.
Tang O, Juraschek SP, Appel LJ. Design Features of Randomized Clinical Trials of Vitamin D and Falls: a Systematic Review. Nutrients. 2018 Jul 26;10(8) PubMed PMID: 30049963.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Design Features of Randomized Clinical Trials of Vitamin D and Falls: A Systematic Review. AU - Tang,Olive, AU - Juraschek,Stephen P, AU - Appel,Lawrence J, Y1 - 2018/07/26/ PY - 2018/06/01/received PY - 2018/07/20/revised PY - 2018/07/24/accepted PY - 2018/7/28/entrez PY - 2018/7/28/pubmed PY - 2018/11/27/medline KW - falls prevention KW - trials KW - vitamin D JF - Nutrients JO - Nutrients VL - 10 IS - 8 N2 - Recent guidelines have advocated against the use of vitamin D supplementation as a means to prevent falls in older adults. However, meta-analyses of the available trials have reached divergent conclusions, and the key design features of these trials have not been well characterized. We conducted a systematic review of 30 randomized trials that reported the effects of vitamin D supplements on falls. Trials were identified by reviewing references of published meta-analyses and updated with a systematic PubMed search. We assessed three key design features: (1) recruitment of participants with vitamin D deficiency or insufficiency; (2) provision of daily oral vitamin D supplementation; and (3) utilization of highly sensitive at-event falls ascertainment. The trials enrolled a median of 337 (IQR: 170-1864) participants. Four (13.3%) trials restricted enrollment to those who were at least vitamin D insufficient, 18 (60.0%) included at least one arm providing daily supplementation, and 16 (53.3%) used at-event reporting. There was substantial heterogeneity between trials, and no single trial incorporated all three key design features. Rather than concluding that vitamin D is ineffective as a means to prevent falls, these findings suggest that existing trial evidence is insufficient to guide recommendations on the use of vitamin D supplements to prevent falls. SN - 2072-6643 UR - https://www.unboundmedicine.com/medline/citation/30049963/Design_Features_of_Randomized_Clinical_Trials_of_Vitamin_D_and_Falls:_A_Systematic_Review_ L2 - http://www.mdpi.com/resolver?pii=nu10080964 DB - PRIME DP - Unbound Medicine ER -