Study To Understand Fall Reduction and Vitamin D in You (STURDY)
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ClinicalTrials.gov Identifier: NCT02166333 |
Recruitment Status :
Terminated
First Posted : June 18, 2014
Results First Posted : May 14, 2021
Last Update Posted : May 14, 2021
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Tracking Information | |||||||||||||||||
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First Submitted Date ICMJE | June 16, 2014 | ||||||||||||||||
First Posted Date ICMJE | June 18, 2014 | ||||||||||||||||
Results First Submitted Date ICMJE | February 4, 2021 | ||||||||||||||||
Results First Posted Date ICMJE | May 14, 2021 | ||||||||||||||||
Last Update Posted Date | May 14, 2021 | ||||||||||||||||
Actual Study Start Date ICMJE | June 30, 2015 | ||||||||||||||||
Actual Primary Completion Date | May 31, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||
Current Primary Outcome Measures ICMJE |
Incidence of First Fall or Death (Whichever Comes First) [ Time Frame: Randomization to 24 months or end of trial, whichever came first ] Falls were ascertained by a monthly fall calendar completed by each participant, scheduled interviews at 1 month and 3 months after randomization and every 3 months thereafter up to 24 months or trial end. Death was ascertained primarily by reports from family or friends.
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Original Primary Outcome Measures ICMJE |
Time to first fall [ Time Frame: A daily fall diary will be collected monthly for 36 months after randomization. ] | ||||||||||||||||
Change History | |||||||||||||||||
Current Secondary Outcome Measures ICMJE |
Change in Gait Speed [ Time Frame: Baseline, 3 months, 12 months and 24 months ] Gait speed in meters per second (m/s) was obtained from the timed 4-meter, usual-paced walk component of the Short Physical Performance Battery. The change in gait speed was obtained as follow-up measure minus baseline measure.
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Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
Descriptive Information | |||||||||||||||||
Brief Title ICMJE | Study To Understand Fall Reduction and Vitamin D in You | ||||||||||||||||
Official Title ICMJE | Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial | ||||||||||||||||
Brief Summary | Vitamin D supplements might substantially reduce the risk of falls, potentially by more than 25%. The proposed study is a clinical trial that will determine the effects of 4 doses of vitamin D (200 International Units [IU]/day, 1000 IU/day, 2000 IU/d and 4000 IU/d) as a means to prevent falls in high-risk adults, ages 70 and older. Results of this trial will be directly relevant to public health and clinical guidelines, and will immediately influence policy. | ||||||||||||||||
Detailed Description | The public health burden of falls in older persons is substantial. Several lines of evidence suggest that vitamin D supplements might reduce the risk of falls, potentially by 25% or more in persons with low serum 25-hydroxyvitamin D [25(OH)D] levels. However, existing evidence is inconsistent and insufficient to guide policy. The trial is a seamless two-stage, Bayesian response-adaptive, randomized dose-finding trial designed to select the best dose of vitamin D supplementation and to potentially confirm the efficacy of that dose for fall prevention and other related outcomes. Participants will be community-dwelling adults, aged 70+ (goal of ~40% black, ~60% women), with a baseline serum 25(OH)D level of 10-29 ng/ml, who are at high risk for falling. In Stage 1 of the adaptive design, participants will be randomly assigned to one of four vitamin D3 (cholecalciferol) doses: 200 IU/d (control), 1000 IU/d, 2000 IU/d, or 4000 IU/d, with assignment probabilities that will vary as falls are reported. Participants will take their assigned pills for two years, or until the study ends, whichever comes first. This stage of the design will select the best non control dose of vitamin D for prevention of falls, or confirm the futility of distinguishing any differences among the non control doses for fall prevention. If a best dose is selected, subsequent participants will be randomized in Stage 2 of the trial into the comparison (200 IU/d) or best dose group, and all participants (Stage 1 and Stage 2) will continue to be followed to potentially confirm efficacy. The investigators anticipate enrolling approximately 1,200 participants over the entire length of the project. The primary outcome is time to first fall (or death) over two years of therapy. Next in importance is the outcome of gait speed. Other outcomes include fall rates, types of falls, balance, muscle strength, frailty, Short Physical Performance Battery (SPPB) score, 6-minute walk time, and physical activity assessed by accelerometry. Falls will be ascertained from fall calendars completed daily by participants and from self-report by phone. In-person follow-up visits will occur at 3, 12, and 24 months, with telephone visits occurring at 1, 6, 9, 15, 18, and 21 months after randomization. Subgroups with potential for greater benefit from vitamin D supplementation are blacks, those with baseline 25(OH)D of 10-19 ng/ml, and those with objective evidence of low physical function. |
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Study Type ICMJE | Interventional | ||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||||||
Actual Enrollment ICMJE |
688 | ||||||||||||||||
Original Estimated Enrollment ICMJE |
1200 | ||||||||||||||||
Actual Study Completion Date ICMJE | June 7, 2019 | ||||||||||||||||
Actual Primary Completion Date | May 31, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 70 Years and older (Older Adult) | ||||||||||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||||||
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Administrative Information | |||||||||||||||||
NCT Number ICMJE | NCT02166333 | ||||||||||||||||
Other Study ID Numbers ICMJE | IRB00063914 U01AG047837 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Johns Hopkins University | ||||||||||||||||
Original Responsible Party | Lawrence Appel, Johns Hopkins University, Professor of Medicine, Epidemiology, and International Health | ||||||||||||||||
Current Study Sponsor ICMJE | Johns Hopkins University | ||||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||||
Collaborators ICMJE | National Institute on Aging (NIA) | ||||||||||||||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||||||||||||||
Verification Date | April 2021 | ||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |