A Randomized Phase II/III Trial Evaluating the Efficacy and Safety of 100 and 125 µg of Calcifediol Weekly Treatment of Severe Vitamin D Deficiency
Nutrients,
Journal Year:
2025,
Volume and Issue:
17(4), P. 672 - 672
Published: Feb. 13, 2025
Background/Objectives:
Given
the
crucial
health
benefits
of
vitamin
D,
addressing
severe
deficiencies
is
a
pressing
medical
concern.
This
study
aimed
to
evaluate
effectiveness
and
safety
two
new
weekly
doses
calcifediol
(100
µg
125
µg)
for
long-term
management
in
patients
with
D
deficiency,
defined
as
plasma
25(OH)D
levels
≤10
ng/mL.
Methods:
was
randomized,
two-cohort,
controlled,
double-blind,
multicentre
phase
II-III
trial.
Subjects
were
randomized
2:2:1
100
µg,
or
placebo.
The
primary
endpoint
proportion
achieving
≥20
ng/mL
and/or
≥30
by
week
16.
Results:
A
total
276
(mean
age:
55.2
years,
SD
15.42)
randomized.
By
16,
92.3%
91.8%
groups,
respectively,
reached
ng/mL,
compared
7.3%
placebo
group.
Levels
achieved
49%
76.4%
(125
participants,
none
Calcifediol
demonstrated
superior
efficacy
at
all
response
time
points
(p
<
0.0001).
Plasma
concentrations
increased
24
remained
stable.
incidence
adverse
events
comparable
across
groups.
Conclusions:
dose
demonstrates
best
profile
tolerability,
providing
reliable
solution
maintaining
adequate
deficiency.
Language: Английский
Analysis of the Efficacy and Safety of Weekly Calcifediol 100 µg in Vitamin D Deficient Patients
Journal of Clinical Medicine,
Journal Year:
2025,
Volume and Issue:
14(9), P. 2976 - 2976
Published: April 25, 2025
Background/Objectives:
Adequate
vitamin
D
levels
are
critical
for
overall
health,
yet
deficiency
remains
prevalent.
This
study
aims
to
evaluate
the
efficacy
and
safety
of
a
standardized
weekly
supplementation
regimen
100
μg
calcifediol
patients
with
varying
degrees
deficiency.
Methods:
A
post
hoc
pool
analysis
was
conducted
from
randomized,
double-blind,
placebo-controlled,
multicenter,
two-cohort
trial.
Cohort
1
included
mild
(25(OH)D
>
10
<
20
ng/mL)
2
severe
≤
ng/mL).
As
both
had
placebo
arms
(ratio
1:2),
pooled
conducted.
The
primary
outcome
percentage
subjects
achieving
25(OH)D
≥
ng/mL
and/or
≥30
at
various
time
points.
Results:
total
401
participants
across
cohorts
were
in
analysis,
130
who
received
271
µg
weekly.
By
week
52,
94.5%
individuals
group
achieved
ng/mL,
compared
25.3%
(p
0.0001).
At
this
same
week,
80.5%
group,
but
none
0.0001),
30
ng/mL.
mean
level
plateaued
around
40.7
weeks
16
52.
frequency
treatment-emergent
adverse
events
similar
groups,
calcifediol.
Conclusions:
Weekly
effectively
restores
deficiencies,
demonstrating
favourable
profile.
Language: Английский