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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency; Falls	Dietary Supplement: 200 IU/d cholecalciferol; Dietary Supplement: 1000 IU/d cholecalciferol; Dietary Supplement: 2000 IU/d cholecalciferol; Dietary Supplement: 4000 IU/d cholecalciferol	Not Applicable

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, 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 dose of vitamin D for prevention of falls, or confirm the futility of distinguishing any differences among the 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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial
Actual Study Start Date :	June 30, 2015
Estimated Primary Completion Date :	March 31, 2020
Estimated Study Completion Date :	March 31, 2020

Arms and Interventions

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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 Name: 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 Name: 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 Name: 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 Name: vitamin D3

Outcome Measures

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Primary Outcome Measures :

1. Time to first fall (or death)-recorded in months [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Change in gait speed [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:	70 Years and older (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

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Contacts

Contact: Lawrence J Appel, MD, MPH	410-955-4156	lappel@jhmi.edu
Contact: Christine Mitchell, ScM		ccarson4@jhmi.edu

Locations

United States, Maryland
ProHealth Clinical Research Unit	Recruiting
Baltimore, Maryland, United States, 21207
Contact 410-281-1600 prohealth@sturdytrial.org
Comstock Center for Public Health Research and Prevention	Recruiting
Hagerstown, Maryland, United States, 21740
Contact 301-791-1847 hagerstown@sturdytrial.org

Sponsors and Collaborators

Johns Hopkins University

National Institute on Aging (NIA)

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

STURDY study website 

Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT02166333 History of Changes
Other Study ID Numbers:	IRB00063914; U01AG047837 ( U.S. NIH Grant/Contract )
First Posted:	June 18, 2014
Last Update Posted:	January 23, 2018
Last Verified:	January 2018

Keywords provided by Johns Hopkins University:

vitamin D; falls; high risk of falling; insufficient or deficient serum vitamin D levels; 10-29 ng/ml

Additional relevant MeSH terms:

Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Vitamins; Vitamin D	Ergocalciferols; Cholecalciferol; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents