Study To Understand Fall Reduction and Vitamin D in You - Full Text View

Purpose

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	Intervention
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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator Primary Purpose: Prevention
Official Title:	Vitamin D Supplements to Prevent Falls in Older Adults: A Dose-Response Trial

Resource links provided by NLM:

MedlinePlus related topics: Falls Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Change in gait speed [ Time Frame: 2 years post-randomization ]


Estimated Enrollment:	1200
Study Start Date:	July 2015
Estimated Study Completion Date:	March 31, 2020
Estimated Primary Completion Date:	March 31, 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02166333

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

Additional Information:

STURDY study website This link exits the ClinicalTrials.gov site


Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT02166333 History of Changes
Other Study ID Numbers:	IRB00063914 U01AG047837 ( U.S. NIH Grant/Contract )
Study First Received:	June 16, 2014
Last Updated:	April 26, 2017

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

ClinicalTrials.gov processed this record on July 27, 2017

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