Study To Understand Fall Reduction and Vitamin D in You

Stopped early · Not applicable

Conditions studied: Vitamin D Deficiency, Falls

In brief

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.

Key facts

Study ID

NCT02166333

Run by

Johns Hopkins University

People needed

688

Starts

2015-06-30

Expected to finish

2019-06-07

Last updated by the study team

2021-05-14

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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