Vitamin D DeficiencySTURDYNCT02166333
Study To Understand Fall Reduction and Vitamin D in You
A study testing 200 IU/d cholecalciferol, 1000 IU/d cholecalciferol and 2000 IU/d cholecalciferol in people with Vitamin D Deficiency and Falls, run by Johns Hopkins University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Falls
- What is being tested?
- 200 IU/d cholecalciferol, 1000 IU/d cholecalciferol and 2000 IU/d cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 688 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2015to 7 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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?
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ProHealth Clinical Research Unit
Baltimore, Maryland, 21207
Comstock Center for Public Health Research and Prevention
Hagerstown, Maryland, 21740
About this study
Official title: 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.
Read the 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.
- Conditions
- Vitamin D Deficiency, Falls
- Being tested
- 200 IU/d cholecalciferol, 1000 IU/d cholecalciferol, 2000 IU/d cholecalciferol, 4000 IU/d cholecalciferol
- Keywords
- vitamin D, falls, high risk of falling, insufficient or deficient serum vitamin D levels, 10-29 ng/ml
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 IU/d cholecalciferolDietary supplement
Also called vitamin D3
1000 IU/d cholecalciferolDietary supplement
Also called vitamin D3
2000 IU/d cholecalciferolDietary supplement
Also called vitamin D3
4000 IU/d cholecalciferolDietary supplement
Also called vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| 200 IU/d | Active comparator | 200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually Receives: Dietary Supplement: 200 IU/d cholecalciferol |
| 1000 IU/d | Active comparator | 1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually Receives: Dietary Supplement: 1000 IU/d cholecalciferol |
| 2000 IU/d | Active comparator | 2000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually Receives: Dietary Supplement: 2000 IU/d cholecalciferol |
| 4000 IU/d | Active comparator | 4000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually Receives: Dietary Supplement: 4000 IU/d cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of First Fall or Death (Whichever Comes 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.
Measured: Randomization to 24 months or end of trial, whichever came first
Secondary outcomes (1)
Change in Gait Speed
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.
Measured: Baseline, 3 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study start30 Jun 2015
- Primary completion31 May 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 688 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lawrence J Appel, MD, MPH, Study chair, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166333
- Sponsor's protocol ID
- IRB00063914
- Other IDs
- U01AG047837
- Acronym
- STURDY
- Status last verified
- Apr 2021
- First submitted
- 16 Jun 2014
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
Juraschek SP, Appel LJ, Lipsitz LA, Miller ER 3rd. Reply to: Comment on: Comparison of supine and seated orthostatic hypotension assessments and their association with falls and orthostatic symptoms. J Am Geriatr Soc. 2023 Feb;71(2):674-676. doi: 10.1111/jgs.18113. Epub 2022 Nov 10. No abstract available.
PubMed 36356235Michos ED, Kalyani RR, Blackford AL, Sternberg AL, Mitchell CM, Juraschek SP, Schrack JA, Wanigatunga AA, Roth DL, Christenson RH, Miller ER 3rd, Appel LJ. The Relationship of Falls With Achieved 25-Hydroxyvitamin D Levels From Vitamin D Supplementation: The STURDY Trial. J Endocr Soc. 2022 Apr 16;6(6):bvac065. doi: 10.1210/jendso/bvac065. eCollection 2022 Jun 1.
PubMed 35592513Juraschek SP, Appel LJ, M Mitchell C, Mukamal KJ, Lipsitz LA, Blackford AL, Cai Y, Guralnik JM, Kalyani RR, Michos ED, Schrack JA, Wanigatunga AA, Miller ER 3rd. Comparison of supine and seated orthostatic hypotension assessments and their association with falls and orthostatic symptoms. J Am Geriatr Soc. 2022 Aug;70(8):2310-2319. doi: 10.1111/jgs.17804. Epub 2022 Apr 22.
PubMed 35451096Cai Y, Wanigatunga AA, Mitchell CM, Urbanek JK, Miller ER 3rd, Juraschek SP, Michos ED, Kalyani RR, Roth DL, Appel LJ, Schrack JA. The effects of vitamin D supplementation on frailty in older adults at risk for falls. BMC Geriatr. 2022 Apr 10;22(1):312. doi: 10.1186/s12877-022-02888-w.
PubMed 35399053Urbanek JK, Roth DL, Karas M, Wanigatunga AA, Mitchell CM, Juraschek SP, Cai Y, Appel LJ, Schrack JA. Free-Living Gait Cadence Measured by Wearable Accelerometer: A Promising Alternative to Traditional Measures of Mobility for Assessing Fall Risk. J Gerontol A Biol Sci Med Sci. 2023 May 11;78(5):802-810. doi: 10.1093/gerona/glac013.
PubMed 35029661Guralnik JM, Sternberg AL, Mitchell CM, Blackford AL, Schrack J, Wanigatunga AA, Michos E, Juraschek SP, Szanton S, Kalyani R, Cai Y, Appel LJ; STURDY Collaborative Research Group. Effects of Vitamin D on Physical Function: Results From the STURDY Trial. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1585-1592. doi: 10.1093/gerona/glab379.
PubMed 34928336Miller HN, Plante TB, Gleason KT, Charleston J, Mitchell CM, Miller ER 3rd, Appel LJ, Juraschek SP. A/B design testing of a clinical trial recruitment website: A pilot study to enhance the enrollment of older adults. Contemp Clin Trials. 2021 Dec;111:106598. doi: 10.1016/j.cct.2021.106598. Epub 2021 Oct 12.
PubMed 34653651Juraschek SP, Miller ER, Wanigatunga AA, Schrack JA, Michos ED, Mitchell CM, Kalyani RR, Appel LJ. Effects of Vitamin D Supplementation on Orthostatic Hypotension: Results From the STURDY Trial. Am J Hypertens. 2022 Feb 1;35(2):192-199. doi: 10.1093/ajh/hpab147.
PubMed 34537827Appel LJ, Michos ED, Mitchell CM, Blackford AL, Sternberg AL, Miller ER 3rd, Juraschek SP, Schrack JA, Szanton SL, Charleston J, Minotti M, Baksh SN, Christenson RH, Coresh J, Drye LT, Guralnik JM, Kalyani RR, Plante TB, Shade DM, Roth DL, Tonascia J; STURDY Collaborative Research Group. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial. Ann Intern Med. 2021 Feb;174(2):145-156. doi: 10.7326/M20-3812. Epub 2020 Dec 8.
PubMed 33284677Plante TB, Gleason KT, Miller HN, Charleston J, McArthur K, Himmelfarb CD, Lazo M, Ford DE, Miller ER 3rd, Appel LJ, Juraschek SP; STURDY Collaborative Research Group. Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study. Clin Trials. 2020 Feb;17(1):30-38. doi: 10.1177/1740774519873657. Epub 2019 Oct 3.
PubMed 31581836Michos ED, Mitchell CM, Miller ER 3rd, Sternberg AL, Juraschek SP, Schrack JA, Szanton SL, Walston JD, Kalyani RR, Plante TB, Christenson RH, Shade D, Tonascia J, Roth DL, Appel LJ; STURDY Collaborative Research Group. 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. Contemp Clin Trials. 2018 Oct;73:111-122. doi: 10.1016/j.cct.2018.08.004. Epub 2018 Aug 20.
PubMed 30138718
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial
- ClinicalTrials.gov ID
- NCT02166333
- Acronym / sponsor ID
- STURDY / IRB00063914
- Conditions
- Vitamin D Deficiency, Falls
- Keywords
- vitamin D, falls, high risk of falling, insufficient or deficient serum vitamin D levels, 10-29 ng/ml
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 688 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Posted 14 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200 IU/d | Active comparator | Dietary Supplement: 200 IU/d cholecalciferol200 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually |
| 1000 IU/d | Active comparator | Dietary Supplement: 1000 IU/d cholecalciferol1000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually |
| 2000 IU/d | Active comparator | Dietary Supplement: 2000 IU/d cholecalciferol2000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually |
| 4000 IU/d | Active comparator | Dietary Supplement: 4000 IU/d cholecalciferol4000 IU/d cholecalciferol (vitamin D3) tablets that can be swallowed or consumed sublingually |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (17 listed)
- 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?
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 200 IU/d cholecalciferolAlso: vitamin D3 | Dietary supplement | 200 IU/d |
| 1000 IU/d cholecalciferolAlso: vitamin D3 | Dietary supplement | 1000 IU/d |
| 2000 IU/d cholecalciferolAlso: vitamin D3 | Dietary supplement | 2000 IU/d |
| 4000 IU/d cholecalciferolAlso: vitamin D3 | Dietary supplement | 4000 IU/d |
Primary outcome
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.
1 secondary outcome
Change in Gait Speed
Time frame: Baseline, 3 months, 12 months and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36356235Juraschek SP, Appel LJ, Lipsitz LA, Miller ER 3rd. Reply to: Comment on: Comparison of supine and seated orthostatic hypotension assessments and their association with falls and orthostatic symptoms. J Am Geriatr Soc. 2023 Feb;71(2):674-676. doi: 10.1111/jgs.18113. Epub 2022 Nov 10. No abstract available.
- Derived from this study: PubMed 35592513Michos ED, Kalyani RR, Blackford AL, Sternberg AL, Mitchell CM, Juraschek SP, Schrack JA, Wanigatunga AA, Roth DL, Christenson RH, Miller ER 3rd, Appel LJ. The Relationship of Falls With Achieved 25-Hydroxyvitamin D Levels From Vitamin D Supplementation: The STURDY Trial. J Endocr Soc. 2022 Apr 16;6(6):bvac065. doi: 10.1210/jendso/bvac065. eCollection 2022 Jun 1.
- Derived from this study: PubMed 35451096Juraschek SP, Appel LJ, M Mitchell C, Mukamal KJ, Lipsitz LA, Blackford AL, Cai Y, Guralnik JM, Kalyani RR, Michos ED, Schrack JA, Wanigatunga AA, Miller ER 3rd. Comparison of supine and seated orthostatic hypotension assessments and their association with falls and orthostatic symptoms. J Am Geriatr Soc. 2022 Aug;70(8):2310-2319. doi: 10.1111/jgs.17804. Epub 2022 Apr 22.
- Derived from this study: PubMed 35399053Cai Y, Wanigatunga AA, Mitchell CM, Urbanek JK, Miller ER 3rd, Juraschek SP, Michos ED, Kalyani RR, Roth DL, Appel LJ, Schrack JA. The effects of vitamin D supplementation on frailty in older adults at risk for falls. BMC Geriatr. 2022 Apr 10;22(1):312. doi: 10.1186/s12877-022-02888-w.
- Derived from this study: PubMed 35029661Urbanek JK, Roth DL, Karas M, Wanigatunga AA, Mitchell CM, Juraschek SP, Cai Y, Appel LJ, Schrack JA. Free-Living Gait Cadence Measured by Wearable Accelerometer: A Promising Alternative to Traditional Measures of Mobility for Assessing Fall Risk. J Gerontol A Biol Sci Med Sci. 2023 May 11;78(5):802-810. doi: 10.1093/gerona/glac013.
- Derived from this study: PubMed 34928336Guralnik JM, Sternberg AL, Mitchell CM, Blackford AL, Schrack J, Wanigatunga AA, Michos E, Juraschek SP, Szanton S, Kalyani R, Cai Y, Appel LJ; STURDY Collaborative Research Group. Effects of Vitamin D on Physical Function: Results From the STURDY Trial. J Gerontol A Biol Sci Med Sci. 2022 Aug 12;77(8):1585-1592. doi: 10.1093/gerona/glab379.
- Derived from this study: PubMed 34653651Miller HN, Plante TB, Gleason KT, Charleston J, Mitchell CM, Miller ER 3rd, Appel LJ, Juraschek SP. A/B design testing of a clinical trial recruitment website: A pilot study to enhance the enrollment of older adults. Contemp Clin Trials. 2021 Dec;111:106598. doi: 10.1016/j.cct.2021.106598. Epub 2021 Oct 12.
- Derived from this study: PubMed 34537827Juraschek SP, Miller ER, Wanigatunga AA, Schrack JA, Michos ED, Mitchell CM, Kalyani RR, Appel LJ. Effects of Vitamin D Supplementation on Orthostatic Hypotension: Results From the STURDY Trial. Am J Hypertens. 2022 Feb 1;35(2):192-199. doi: 10.1093/ajh/hpab147.
- Derived from this study: PubMed 33284677Appel LJ, Michos ED, Mitchell CM, Blackford AL, Sternberg AL, Miller ER 3rd, Juraschek SP, Schrack JA, Szanton SL, Charleston J, Minotti M, Baksh SN, Christenson RH, Coresh J, Drye LT, Guralnik JM, Kalyani RR, Plante TB, Shade DM, Roth DL, Tonascia J; STURDY Collaborative Research Group. The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial. Ann Intern Med. 2021 Feb;174(2):145-156. doi: 10.7326/M20-3812. Epub 2020 Dec 8.
- Derived from this study: PubMed 31581836Plante TB, Gleason KT, Miller HN, Charleston J, McArthur K, Himmelfarb CD, Lazo M, Ford DE, Miller ER 3rd, Appel LJ, Juraschek SP; STURDY Collaborative Research Group. Recruitment of trial participants through electronic medical record patient portal messaging: A pilot study. Clin Trials. 2020 Feb;17(1):30-38. doi: 10.1177/1740774519873657. Epub 2019 Oct 3.
- Derived from this study: PubMed 30138718Michos ED, Mitchell CM, Miller ER 3rd, Sternberg AL, Juraschek SP, Schrack JA, Szanton SL, Walston JD, Kalyani RR, Plante TB, Christenson RH, Shade D, Tonascia J, Roth DL, Appel LJ; STURDY Collaborative Research Group. 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. Contemp Clin Trials. 2018 Oct;73:111-122. doi: 10.1016/j.cct.2018.08.004. Epub 2018 Aug 20.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Vitamin D Deficiency
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence J Appel, MD, MPH study chair
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 200 IU/d cholecalciferol, 1000 IU/d cholecalciferol and 2000 IU/d cholecalciferol in people with Vitamin D Deficiency and Falls, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of First Fall or Death (Whichever Comes First) (time frame: Randomization to 24 months or end of trial, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166333, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.