Study To Understand Fall Reduction and Vitamin D in You (STURDY)

April 22, 2021 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

688

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21207
        • ProHealth Clinical Research Unit
      • Hagerstown, Maryland, United States, 21740
        • Comstock Center for Public Health Research and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 70 and older
  • Non-institutionalized
  • High risk for falling, defined by a 'yes' response to at least one of the following:
  • 1. Have you fallen and hurt yourself in the past year?
  • 2. Have you fallen 2 or more times in the past year?
  • 3. Are you afraid that you might fall because of balance or walking problems?
  • 4. Do you have difficulty maintaining your balance when bathing, dressing, or getting in and out of a chair?
  • 5. Do you use a cane, walker, or other device when walking inside or outside your home?
  • Serum vitamin D [25(OH)D] level of 10-29 ng/ml
  • Able to provide informed consent
  • Willing to accept randomization to each vitamin D dose
  • One of the following:
  • 1. No vitamin D supplementation at baseline
  • 2. Average daily vitamin D supplementation judged by study staff as being consistent with the goal of 1000 IU/day or less at screening and willing to continue the dose unchanged throughout the trial
  • One of the following:
  • 1. No calcium supplementation at baseline
  • 2. Average daily calcium supplementation judged by study staff as being consistent with the goal of 1200 mg/day or less at screening and willing to continue the dose unchanged throughout the trial

Exclusion Criteria:

  • Cognitive impairment, defined by Mini-Mental State Exam (MMSE) score <24
  • Hypercalcemia, serum Ca++ 11.0 mg/dl or higher or >10.5 mg/dl (confirmed)
  • Hypocalcemia, serum Ca++ <8.5 mg/dl
  • Kidney, ureteral, or bladder stones made of calcium compounds (2 or more in lifetime, or 1 in the last 2 years); in the absence of information on the type of stone, stones will be assumed to be made of calcium compounds
  • Planning to move out of area within 2 years, where plans would prevent compliance with the study protocol
  • Disease or condition expected to cause death or to prevent compliance with the study protocol in the next 2 years
  • Participation in another trial of vitamin D or falls, or any trial that might affect the risk of falls
  • Lactose allergy (lactose intolerance is okay)
  • Use of any form of oral or injected calcitriol (brand names: Rocaltrol (R), Calcijex (R), and Zemplar (R); generic names: calcitriol, paricalcitol, doxycalcitriol, 22-oxacalcitriol)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 200 IU/d
200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
Dietary supplement: 200 IU/d cholecalciferol
Other Names:
  • vitamin D3
Active Comparator: 1000 IU/d
1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
Dietary supplement: 1000 IU/d cholecalciferol
Other Names:
  • vitamin D3
Active Comparator: 2000 IU/d
2000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
Dietary supplement: 2000 IU/d cholecalciferol
Other Names:
  • vitamin D3
Active Comparator: 4000 IU/d
4000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
Dietary supplement: 4000 IU/d cholecalciferol
Other Names:
  • vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Randomization to 24 months or end of trial, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, 12 months and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Study Chair: Lawrence J Appel, MD, MPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2015

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

June 7, 2019

Study Registration Dates

First Submitted

June 16, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00063914
  • U01AG047837 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data and data dictionary will be available at https://archive.data.jhu.edu/ starting one year after publication of the primary outcome results, contingent upon Institutional Review Board (IRB) approval.

IPD Sharing Time Frame

One year after publication of primary outcome results. Data are expected to be available in December 2021. Data are expected to remain available in perpetuity.

IPD Sharing Access Criteria

Data will be available at https://archive.data.jhu.edu/ contingent on IRB approval of their use.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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