ArticleContemporary clinical trials2018
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.
Article in Contemporary clinical trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02166333 (Vitamin D Supplements to Prevent Falls in Older Adults), which is not on this map. Cited by 18 papers.
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.
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.
Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial
Who cites it
18 citing papers in PubMed.
- Associations of Hypertension and Orthostatic Hypotension With Subclinical Cardiovascular Disease.The journals of gerontology. Series A, Biological sciences and medical sciences · 2024Trial
- Timing of orthostatic hypotension and its relationship with falls in older adults.Journal of the American Geriatrics Society · 2023Trial
- The association of vitamin D supplementation and serum vitamin D levels with physical activity in older adults: Results from a randomized trial.Journal of the American Geriatrics Society · 2023Trial
- Effects of Vitamin D on Physical Function: Results From the STURDY Trial.The journals of gerontology. Series A, Biological sciences and medical sciences · 2022Trial
- The effects of vitamin D supplementation on frailty in older adults at risk for falls.BMC geriatrics · 2022Trial
- Effects of Vitamin D Supplementation on Orthostatic Hypotension: Results From the STURDY Trial.American journal of hypertension · 2022Trial
- A/B design testing of a clinical trial recruitment website: A pilot study to enhance the enrollment of older adults.Contemporary clinical trials · 2021Trial
- The effects of vitamin D supplementation on types of falls.Journal of the American Geriatrics Society · 2021Trial
- Trial
- Free-Living Gait Cadence Measured by Wearable Accelerometer: A Promising Alternative to Traditional Measures of Mobility for Assessing Fall Risk.The journals of gerontology. Series A, Biological sciences and medical sciences · 2023Article
- Comparison of supine and seated orthostatic hypotension assessments and their association with falls and orthostatic symptoms.Journal of the American Geriatrics Society · 2022Article
- Article
- The Relationship of Falls With Achieved 25-Hydroxyvitamin D Levels From Vitamin D Supplementation: The STURDY Trial.Journal of the Endocrine Society · 2022Article
- The health effects of vitamin D supplementation: evidence from human studies.Nature reviews. Endocrinology · 2022Review
- Assessment of Physical Activity in Adults Using Wrist Accelerometers.Epidemiologic reviews · 2022Review
- The Bayesian Design of Adaptive Clinical Trials.International journal of environmental research and public health · 2021Review
- Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study.Clinical trials (London, England) · 2020Article
- Vitamin D and Calcium Supplements: Helpful, Harmful, or Neutral for Cardiovascular Risk?Methodist DeBakey cardiovascular journalReview
Corrections and comments
- Erratum issued
Authors and funding
16 authors.
Funding
Abstract
Prior evidence suggests that vitamin D supplementation may reduce fall risk, but existing data are inconsistent and insufficient to guide policy. We designed a two-stage Bayesian response-adaptive dose-finding and seamless confirmatory randomized trial of vitamin D supplementation to prevent falls. Up to 1200 community-dwelling persons, aged ≥70 years, of predominantly white and African-American race, with serum 25(OH)D concentrations of 10-29 ng/mL and at elevated fall risk, will be randomized to one of four vitamin D3 (cholecalciferol) supplement doses: 200 (control), 1000, 2000, or 4000 IU/day and treated for up to 2 years. Stage 1 is designed to identify the best of the non-control doses for fall prevention. If a best dose is selected, Stage 2 will start seamlessly, with enrollees assigned to control or the best dose in Stage 1 continuing on that dose unchanged, enrollees assigned to the two non-control, non-best doses in Stage 1 switched to the best dose, and new enrollees randomly assigned 1:1 to control or the best dose. In Stage 2, we will compare the control dose group to the best dose group to potentially confirm the efficacy of that dose for fall prevention. The primary outcome measure in both stages is time to first fall or death, whichever comes first. Falls are ascertained from calendars, scheduled interviews, or interim self-reports. Secondary outcome measures include time to each component of the composite primary outcome and gait speed. Additional outcomes include the Short Physical Performance Battery score, physical activity level (assessed by accelerometry), and frailty score. CLINICAL
trial registrationNCT02166333.
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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.