The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial.
Journal
Annals of internal medicine
ISSN: 1539-3704
Titre abrégé: Ann Intern Med
Pays: United States
ID NLM: 0372351
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
pubmed:
8
12
2020
medline:
2
3
2021
entrez:
7
12
2020
Statut:
ppublish
Résumé
Vitamin D supplementation may prevent falls in older persons, but evidence is inconsistent, possibly because of dosage differences. To compare the effects of 4 doses of vitamin D 2-stage Bayesian, response-adaptive, randomized trial. (ClinicalTrials.gov: NCT02166333). 2 community-based research units. 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. 200 (control), 1000, 2000, or 4000 IU of vitamin D Time to first fall or death over 2 years (primary outcome). 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; The control group received 200 IU of vitamin D In older persons with elevated fall risk and low serum 25-(OH)D levels, vitamin D National Institute on Aging.
Sections du résumé
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
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
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;
LIMITATIONS
The control group received 200 IU of vitamin D
CONCLUSION
In older persons with elevated fall risk and low serum 25-(OH)D levels, vitamin D
PRIMARY FUNDING SOURCE
National Institute on Aging.
Identifiants
pubmed: 33284677
doi: 10.7326/M20-3812
pmc: PMC8240534
mid: NIHMS1705793
doi:
Substances chimiques
Vitamins
0
Vitamin D
1406-16-2
25-hydroxyvitamin D
A288AR3C9H
Banques de données
ClinicalTrials.gov
['NCT02166333']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
145-156Subventions
Organisme : NIDDK NIH HHS
ID : K23 DK093583
Pays : United States
Organisme : NIDDK NIH HHS
ID : T32 DK007732
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL007180
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30 DK072488
Pays : United States
Organisme : NIA NIH HHS
ID : U01 AG047837
Pays : United States
Organisme : NHLBI NIH HHS
ID : K23 HL135273
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR003098
Pays : United States
Organisme : NIA NIH HHS
ID : K01 AG048765
Pays : United States
Investigateurs
Nicole Cronin
(N)
Scott McClure
(S)
Jacek K Urbanek
(JK)
Jeremy Walston
(J)
Amal A Wanigatunga
(AA)
Shumon Chattopadhyay
(S)
John Dodge
(J)
Cathleen Ewing
(C)
Sana Haider
(S)
Stephanie C Holland
(SC)
Rosetta Jackson
(R)
Andrea Lears
(A)
Curtis Meinert
(C)
Michael Smith
(M)
Mark L Van Natta
(ML)
Annette Wagoner
(A)
J Denise Bennett
(JD)
Pamela Bowers
(P)
Patricia Crowley
(P)
Tammy Crunkleton
(T)
Briana Dick
(B)
Rebecca Evans
(R)
Mary Godwin
(M)
Lynne Hammann
(L)
Deborah Hawks
(D)
Karen Horning
(K)
Erika Hull
(E)
Brandi Mills
(B)
Leann Raley
(L)
Amanda Reed
(A)
Rhonda Reeder
(R)
Cassie Reid
(C)
Melissa Shuda
(M)
Adria Spikes
(A)
Rhonda Stouffer
(R)
Kelly Weicht
(K)
Caroline Abbas
(C)
Bernellyn Carey
(B)
Syree Davis
(S)
Naomi DeRoche-Brown
(N)
Debra Gayles
(D)
Sherlina Holland
(S)
Ina Glenn-Smith
(I)
Duane Johnson
(D)
Mia Johnson
(M)
Eva Keyes
(E)
Kristen McArthur
(K)
Danielle Santiago
(D)
Chanchai Sapun
(C)
Valerie Sneed
(V)
Lee Swartz
(L)
Letitia Thomas
(L)
Show-Hong Duh
(SH)
Heather Rebuck
(H)
Clifford Rosen
(C)
Thomas Cook
(T)
Karen E Hansen
(KE)
Anne Kenny
(A)
Sue Shapses
(S)
Judy Hannah
(J)
Sergei Romashkan
(S)
Cindy D Davis
(CD)
Christopher T Sempos
(CT)
J C Gallagher
(JC)
Commentaires et corrections
Type : CommentIn
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