Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT02166333 |
Other study ID # |
IRB00063914 |
Secondary ID |
U01AG047837 |
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 30, 2015 |
Est. completion date |
June 7, 2019 |
Study information
Verified date |
April 2021 |
Source |
Johns Hopkins University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 70 and older. Results of this trial will be
directly relevant to public health and clinical guidelines, and will immediately influence
policy.
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.