Study To Understand Fall Reduction and Vitamin D in You (STURDY)
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| ClinicalTrials.gov Identifier: NCT02166333 |
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Recruitment Status :
Recruiting
First Posted : June 18, 2014
Last Update Posted : August 6, 2018
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| 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 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 200 IU/d
200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
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Dietary Supplement: 200 IU/d cholecalciferol
Other Name: vitamin D3 |
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Active Comparator: 1000 IU/d
1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
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Dietary Supplement: 1000 IU/d cholecalciferol
Other Name: vitamin D3 |
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Active Comparator: 2000 IU/d
2000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
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Dietary Supplement: 2000 IU/d cholecalciferol
Other Name: vitamin D3 |
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Active Comparator: 4000 IU/d
4000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually
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Dietary Supplement: 4000 IU/d cholecalciferol
Other Name: vitamin D3 |
- Time to first fall (or death)-recorded in months [ Time Frame: 24 months ]
- Change in gait speed [ Time Frame: 2 years ]
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| Ages Eligible for Study: | 70 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02166333
| Contact: Lawrence J Appel, MD, MPH | 410-955-4156 | lappel@jhmi.edu | |
| Contact: Christine Mitchell, ScM | ccarson4@jhmi.edu |
| 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 | |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| Last Update Posted: | August 6, 2018 |
| Last Verified: | August 2018 |
Keywords provided by Johns Hopkins University:
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vitamin D falls high risk of falling insufficient or deficient serum vitamin D levels 10-29 ng/ml |
Additional relevant MeSH terms:
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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 |