Evidence map›Paper›PMID 35399053›Full record

Trial reportBMC geriatrics2022

The effects of vitamin D supplementation on frailty in older adults at risk for falls.

Yurun Cai, Amal A Wanigatunga, Christine M Mitchell, Jacek K Urbanek, Edgar R Miller, Stephen P Juraschek, Erin D Michos, Rita R Kalyani, David L Roth, Lawrence J Appel and 1 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC geriatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02166333 (Vitamin D Supplements to Prevent Falls in Older Adults), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
2.9field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02166333 naterminatednot on this map

Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial

TypeinterventionalSponsorJohns Hopkins UniversityRan2015 to 2019Enrolled688ConditionsVitamin D Deficiency, FallsArms200 IU/d cholecalciferol, 1000 IU/d cholecalciferol, 2000 IU/d cholecalciferol, 4000 IU/d cholecalciferol
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
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  4. Associations of Hypertension and Orthostatic Hypotension With Subclinical Cardiovascular Disease.The journals of gerontology. Series A, Biological sciences and medical sciences · 2024
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  8. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 3 institutions in 1 country.

Yurun CaiDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. yuc199@pitt.edu.
Amal A WanigatungaDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Christine M MitchellDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Jacek K UrbanekCenter On Aging and Health, Johns Hopkins University, Baltimore, MD, USA.
Edgar R MillerWelch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University and Medical Institutions, Baltimore, MD, USA.
Stephen P JuraschekDivision of General Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Erin D MichosWelch Center for Prevention, Epidemiology, and Clinical Research, Johns Hopkins University and Medical Institutions, Baltimore, MD, USA.
Rita R KalyaniCenter On Aging and Health, Johns Hopkins University, Baltimore, MD, USA.
David L RothCenter On Aging and Health, Johns Hopkins University, Baltimore, MD, USA.
Lawrence J AppelDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Jennifer A SchrackDepartment of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Johns Hopkins Medicine · USJohns Hopkins University · USBeth Israel Deaconess Medical Center · US

Funding

QAQC Johns Hopkins Institute for Clinical and Translational ResearchUL1TR003098 · NCATS · JOHNS HOPKINS UNIVERSITY · PI FORD, DANIEL ERNEST · 2019 to 2023
$57.7M
Technological Assessment and Solutions Core - RC4P30AG021334 · NIA · JOHNS HOPKINS UNIVERSITY · PI Jeremy D Walston · 2003 to 2026
$33.2M
Research BaseP30DK072488 · NIDDK · UNIVERSITY OF MARYLAND BALTIMORE · PI MITCHELL, BRAXTON D, TAYLOR, SIMEON I. · 2005 to 2019
$17.3M
Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response TrialU01AG047837 · NIA · JOHNS HOPKINS UNIVERSITY · PI APPEL, LAWRENCE JOHN · 2014 to 2019
$9.5M
NCATS NIH HHS UL1 TR003098NIA NIH HHS P30 AG021334NIA NIH HHS U01 AG047837NIDDK NIH HHS P30 DK072488
6 · The paper itself

Abstract

backgroundLow serum 25-hydroxyvitamin D [25(OH)D] level is associated with a greater risk of frailty, but the effects of daily vitamin D supplementation on frailty are uncertain. This secondary analysis aimed to examine the effects of vitamin D supplementation on frailty using data from the Study To Understand Fall Reduction and Vitamin D in You (STURDY).

methodsThe STURDY trial, a two-stage Bayesian, response-adaptive, randomized controlled trial, enrolled 688 community-dwelling adults aged ≥ 70 years with a low serum 25(OH)D level (10-29 ng/mL) and elevated fall risk. Participants were initially randomized to 200 IU/d (control dose; n = 339) or a higher dose (1000 IU/d, 2000 IU/d, or 4000 IU/d; n = 349) of vitamin D3. Once the 1000 IU/d was selected as the best higher dose, other higher dose groups were reassigned to the 1000 IU/d group and new enrollees were randomized 1:1 to 1000 IU/d or control group. Data were collected at baseline, 3, 12, and 24 months. Frailty phenotype was based on number of the following conditions: unintentional weight loss, exhaustion, slowness, low activity, and weakness (≥ 3 conditions as frail, 1 or 2 as pre-frail, and 0 as robust). Cox proportional hazard models estimated the risk of developing frailty, or improving or worsening frailty status at follow-up. All models were adjusted for demographics, health conditions, and further stratified by baseline serum 25(OH)D level (insufficiency (20-29 ng/mL) vs. deficiency (10-19 ng/mL)).

resultsAmong 687 participants (mean age 77.1 ± 5.4, 44% women) with frailty assessment at baseline, 208 (30%) were robust, 402 (59%) were pre-frail, and 77 (11%) were frail. Overall, there was no significant difference in risk of frailty outcomes comparing the pooled higher doses (PHD; ≥ 1000 IU/d) vs. 200 IU/d. When comparing each higher dose vs. 200 IU/d, the 2000 IU/d group had nearly double the risk of worsening frailty status (HR = 1.89, 95% CI: 1.13-3.16), while the 4000 IU/d group had a lower risk of developing frailty (HR = 0.22, 95% CI: 0.05-0.97). There were no significant associations between vitamin D doses and frailty status in the analyses stratified by baseline serum 25(OH)D level.

conclusionsHigh dose vitamin D supplementation did not prevent frailty. Significant subgroup findings might be the results of type 1 error.

trial registrationClinicalTrials.gov: NCT02166333 .

Indexed as

FrailtyVitamin D DeficiencyAgedBayes TheoremDietary SupplementsDouble-Blind MethodFemaleHumansMaleVitamin DVitaminsVitamin DVitaminsFrailtyNutrition supplementationRandomized controlled trialVitamin D3

Identifiers

PMID35399053
PMCPMC8994906
OpenAlexW4223565840

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.