Study To Understand Fall Reduction and Vitamin D in You (NCT02166333) | Clinical Trial Compass
TerminatedNot Applicable
Study To Understand Fall Reduction and Vitamin D in You
United States688 participantsStarted 2015-06-30
Plain-language 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.
Who can participate
Age range70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 calciu…
What they're measuring
1
Incidence of First Fall or Death (Whichever Comes First)
Timeframe: Randomization to 24 months or end of trial, whichever came first