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Tytuł:
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The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial.
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Autorzy:
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Appel LJ; Johns Hopkins University, Baltimore, Maryland (L.J.A., E.R.M., D.L.R.).
Michos ED; Johns Hopkins University School of Medicine, Baltimore, Maryland (E.D.M., A.L.B., R.R.K.).
Mitchell CM; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Blackford AL; Johns Hopkins University School of Medicine, Baltimore, Maryland (E.D.M., A.L.B., R.R.K.).
Sternberg AL; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Miller ER 3rd; Johns Hopkins University, Baltimore, Maryland (L.J.A., E.R.M., D.L.R.).
Juraschek SP; Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts (S.P.J.).
Schrack JA; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Szanton SL; Johns Hopkins University School of Nursing, Baltimore, Maryland (S.L.S.).
Charleston J; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Minotti M; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Baksh SN; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Christenson RH; University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., J.M.G.).
Coresh J; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Drye LT; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Guralnik JM; University of Maryland School of Medicine, Baltimore, Maryland (R.H.C., J.M.G.).
Kalyani RR; Johns Hopkins University School of Medicine, Baltimore, Maryland (E.D.M., A.L.B., R.R.K.).
Plante TB; Larner College of Medicine at the University of Vermont, Burlington, Vermont (T.B.P.).
Shade DM; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
Roth DL; Johns Hopkins University, Baltimore, Maryland (L.J.A., E.R.M., D.L.R.).
Tonascia J; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland (C.M.M., A.L.S., J.A.S., J.C., M.M., S.N.B., J.C., L.T.D., D.M.S., J.T.).
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Corporate Authors:
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STURDY Collaborative Research Group
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Źródło:
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Annals of internal medicine [Ann Intern Med] 2021 Feb; Vol. 174 (2), pp. 145-156. Date of Electronic Publication: 2020 Dec 08.
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Typ publikacji:
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Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural
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Język:
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English
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Imprint Name(s):
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Publication: <2001->: Philadelphia, PA : American College of Physicians--American Society of Internal Medicine
Original Publication: Philadelphia [etc.] American College of Physicians.
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MeSH Terms:
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Dietary Supplements*
Accidental Falls/*prevention & control
Vitamin D/*therapeutic use
Vitamins/*therapeutic use
Accidental Falls/statistics & numerical data ; Aged ; Bayes Theorem ; Drug Dosage Calculations ; Female ; Humans ; Male ; Vitamin D/administration & dosage ; Vitamin D/analogs & derivatives ; Vitamin D/blood ; Vitamin D Deficiency/drug therapy ; Vitamins/administration & dosage
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References:
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Grant Information:
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K23 DK093583 United States DK NIDDK NIH HHS; T32 DK007732 United States DK NIDDK NIH HHS; T32 HL007180 United States HL NHLBI NIH HHS; P30 DK072488 United States DK NIDDK NIH HHS; U01 AG047837 United States AG NIA NIH HHS; K23 HL135273 United States HL NHLBI NIH HHS; UL1 TR003098 United States TR NCATS NIH HHS; K01 AG048765 United States AG NIA NIH HHS
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Contributed Indexing:
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Investigator: N Cronin; S McClure; JK Urbanek; J Walston; AA Wanigatunga; S Chattopadhyay; J Dodge; C Ewing; S Haider; SC Holland; R Jackson; A Lears; C Meinert; M Smith; ML Van Natta; A Wagoner; JD Bennett; P Bowers; P Crowley; T Crunkleton; B Dick; R Evans; M Godwin; L Hammann; D Hawks; K Horning; E Hull; B Mills; L Raley; A Reed; R Reeder; C Reid; M Shuda; A Spikes; R Stouffer; K Weicht; C Abbas; B Carey; S Davis; N DeRoche-Brown; D Gayles; S Holland; I Glenn-Smith; D Johnson; M Johnson; E Keyes; K McArthur; D Santiago; C Sapun; V Sneed; L Swartz; L Thomas; SH Duh; H Rebuck; C Rosen; T Cook; KE Hansen; A Kenny; S Shapses; J Hannah; S Romashkan; CD Davis; CT Sempos; JC Gallagher
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Molecular Sequence:
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ClinicalTrials.gov NCT02166333
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Substance Nomenclature:
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0 (Vitamins)
1406-16-2 (Vitamin D)
A288AR3C9H (25-hydroxyvitamin D)
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Entry Date(s):
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Date Created: 20201207 Date Completed: 20210301 Latest Revision: 20240328
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Update Code:
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20240329
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PubMed Central ID:
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PMC8240534
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DOI:
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10.7326/M20-3812
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PMID:
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33284677
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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. (ClinicalTrials.gov: NCT02166333).
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.
Primary Funding Source: National Institute on Aging.
Comment in: Ann Intern Med. 2021 Feb;174(2):261-262. (PMID: 33284678)
Comment in: JPEN J Parenter Enteral Nutr. 2024 Jan;48(1):128-130. (PMID: 37376916)
