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COMPARISON OF SIDERAL® AND STANDARD ORAL IRON THERAPIES IN
CHILDREN WITH CHRONIC KIDNEY DISEASE: EFFICACY AND TOLERABILITY
STUDY
Ашурова Ноила Шухратовна
PhD, ассистент кафедры Терапевтических предметов Университета Зармед;
ORCiD 0009-0000-3439-2856
e-mail:
Мурадова Эмма Владимировна
PhD, доцент кафедры Микробиологии, вирусологии, иммунологии,
Самаркандский Государственный Медицинский Университет
ОRCID ID 0009-0005-6147-9769
e-mаil:
Ганжиян Наринэ Эмильевна
студентка 533 группы, Лечебного факультета
Самаркандский Государственный Медицинский Университет.
https://doi.org/10.5281/zenodo.17497226
Abstract.
The study compares SiderAL® (Sucrosomial® Iron) and traditional ferrous
sulfate in treating anemia in children with chronic kidney disease (CKD). Sixty children aged 5–
15 years with CKD stages II–IV and iron deficiency anemia participated in a 12-week
randomized study. Results showed that both therapies improved hemoglobin and serum iron
levels, but SiderAL® produced significantly better results and fewer gastrointestinal side effects
(6.7% vs. 26.7%). Treatment adherence was also higher with SiderAL® (93.3%). Thus,
SiderAL® proved to be more effective and better tolerated than standard iron preparations for
managing anemia in children with CKD.
Keywords:
Children, Chronic Kidney Disease, Anemia, Iron Deficiency, Sideral®,
Sucrosomial® Iron.
Background.
Anemia is one of the most common and clinically significant
complications of chronic kidney disease (CKD) in children, leading to impaired physical and
cognitive development and a decreased quality of life [1,2].
The main etiological factor of anemia in CKD is iron deficiency, which may develop due
to both absolute and functional depletion of iron stores [3,4].
However, the effectiveness of traditional oral iron preparations is often limited by their
low bioavailability and the high incidence of gastrointestinal side effects [5,6].
Objective.
To compare the efficacy and tolerability of SiderAL® (Sucrosomial® Iron)
and traditional oral iron preparations in children with CKD and anemia.
Materials and Methods.
A prospective, randomized, open-label, comparative study was
conducted in 60 children with stage II-IV CKD and laboratory-confirmed iron deficiency
anemia.
Patients were divided into two equal groups:
− Group I (n=30): received ferrous sulfate;
– Group II (n=30): received SiderAL®.
The duration of therapy was 12 weeks. The following parameters were evaluated:
hemoglobin (Hb), serum iron (Fe), total iron-binding capacity (TIBC), transferrin saturation
(TSAT), frequency of adverse events, and treatment adherence (compliance).
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Results.
After therapy, both groups demonstrated a statistically significant increase in
serum iron and hemoglobin levels (
p < 0.001
).
The increase in Hb was more pronounced in the SiderAL® group (+30.8 g/L) compared
to the ferrous sulfate group (+14.0 g/L,
p < 0.001
).
The frequency of gastrointestinal adverse effects was notably lower in patients receiving
SiderAL® (6.7%) compared to those receiving ferrous sulfate (26.7%).
Introduction
Chronic kidney disease in children is characterized by a progressive decline in renal
function and the development of systemic complications, among which anemia is one of the
most common and clinically significant manifestations [1,14].
Anemia in CKD results from decreased endogenous erythropoietin synthesis, iron
deficiency, chronic inflammation, and elevated hepcidin levels [3,7].
Iron deficiency in patients with CKD can be absolute, caused by insufficient intake and
chronic iron loss, or functional, due to impaired mobilization of stored iron under the influence
of proinflammatory cytokines [8,15,16]. Increased hepcidin levels during inflammation inhibit
the release of iron from enterocytes and macrophages, further exacerbating anemia [7,9,17,18].
Oral iron preparations have traditionally been used for the correction of anemia; however,
their low bioavailability and frequent gastrointestinal side effects−such as nausea, constipation,
and abdominal pain−often reduce treatment adherence [2,10].
Recent pharmaceutical innovations have focused on improving iron absorption and
tolerability. One of the most promising formulations is Sucrosomial® Iron, the technology used
in the SiderAL® preparation, which allows iron to be transported through the intestinal
epithelium without direct contact with the mucosa [4,5,11,18].
Recent studies have shown that sucrosomial iron has higher bioavailability and a lower
incidence of gastrointestinal side effects compared with traditional iron salts [6,11,14]. However,
evidence regarding the use of SiderAL® in pediatric nephrology remains limited, which
determined the relevance of the present study.
Objective.
To conduct a comparative evaluation of the efficacy and tolerability of
SiderAL® and traditional ferrous sulfate in the treatment of anemia in children with chronic
kidney disease.
Materials and Methods
A prospective, randomized, open-label study was conducted involving 60 children aged
5–15 years with CKD stages II–IV and laboratory-confirmed iron deficiency anemia.
The patients were divided into two equal groups:
Group I (n = 30): received ferrous sulfate at a dose of 3–6 mg of elemental iron per kg per
day;
Group II (n = 30): received SiderAL® (Sucrosomial® Iron) at a dose of 1 mg/kg/day for
children under 6 years and 30 mg/day for those aged 6 years and older.
The treatment duration was 12 weeks.
Inclusion criteria: age 5–15 years; CKD stages II-IV; hemoglobin below age-adjusted
normal values; TSAT < 20%.
Exclusion criteria: hemoglobin < 7 g/dL; acute inflammatory diseases; gastrointestinal
pathology; previous parenteral iron therapy within 1 month.
The following parameters were assessed before and after treatment:
Hemoglobin (Hb, g/L);
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Serum iron (Fe, µmol/L);
Total iron-binding capacity (TIBC, µmol/L);
Transferrin saturation (TSAT, %);
Frequency of adverse effects and treatment adherence (compliance).
Statistical analysis was performed using SPSS 26.0. Data were expressed as M ± m
(mean ± standard error of the mean).
Differences were considered statistically significant at
p < 0.05
.
Results and Discussion
Dynamics of Iron Metabolism Parameters.
Before the start of therapy, all patients
showed laboratory signs of iron deficiency anemia: Fe − 6.55 ± 0.29 µmol/L; Hb − 76.26 ± 1.87
g/L; TSAT − 14.11 ± 1.26%.
After 12 weeks of treatment, a significant improvement in laboratory parameters was
observed in both groups; however, the improvement was more pronounced in the SiderAL®
group (Table 1).
Table 1
Comparative changes in iron metabolism and hemoglobin parameters in children with
CKD after 12 weeks of therapy (M ± m)
Parameter
Control
group, M±m
(n=20)
Before
treatment
(n=60)
After ferrous
sulfate (n=30)
After
SiderAL®
(n=30)
p₁ (before/
after
treatment)
p₂ (between
groups after
treatment)
Serum iron,
mmol/l
18.35±2.26
6,55±0,29
10,35 ± 0,40
14,36 ± 0,54
<0,001
<0,001
Hemoglobin,
g/l
125.0±4.74 76,26±1,87
90,30 ± 1,02
107,10 ± 0,64
<0,001
<0,001
TIBC, mmol/l
60.00±6.32 53,41±3,43
59,04 ± 3,33
55,80 ± 1,21
>0,05
>0,05
TSAT, %
30.5±5.37
14,11±1,26
18,10 ± 1,16
22,01 ± 0,97
<0,01
<0,01
Note:
p₁
−
statistical
significance
of
within-group
dynamics;
p₂ − statistical significance of differences between groups after treatment.
Results and Discussion
In both groups, a statistically significant increase in Hb and Fe levels was observed (
p <
0.001
).
However, the improvement was more pronounced in the SiderAL® group. This finding is
consistent with other studies demonstrating higher absorption and efficacy of sucrosomial iron in
chronic diseases [4,6,9].
The TSAT increased by 7.9 percentage points in the SiderAL® group compared with 4
percentage points in the ferrous sulfate group (
p < 0.01
), indicating enhanced iron transport to
the bone marrow [7,11].
TIBC did not change significantly (
p > 0.05
), which is likely related to the stability of
transferrin levels under chronic inflammatory conditions associated with CKD [3,10].
Tolerability and Compliance
In the ferrous sulfate group, gastrointestinal side effects such as nausea, constipation, and
abdominal pain were reported in 8 (26.7%) children, whereas in the SiderAL® group, they
occurred only in 2 (6.7%) patients (
p < 0.05
).
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Treatment compliance was also higher in the SiderAL® group (93.3%) compared with
the ferrous sulfate group (76.6%), confirming the better tolerability and acceptability of
SiderAL® [5,9].
Thus, therapy with SiderAL® led to a more pronounced improvement in hematopoietic
parameters, with minimal adverse effects and high treatment adherence.
Conclusions
1.
Administration of SiderAL® in children with CKD and anemia resulted in a significantly
greater increase in Hb and Fe levels compared to traditional iron preparations (
p < 0.001
) [18].
2.
SiderAL® demonstrated high bioavailability and a lower incidence of side effects (6.7%
vs. 26.7%) [18].
3.
Treatment adherence in the SiderAL® group was 93.3%, indicating superior tolerability
and ease of use.
4.
The sucrosomial form of iron can be considered an effective alternative to conventional
ferrous salts for treating anemia in children with CKD [13,14,18].
Practical Recommendations
1.
In children with CKD and anemia, it is recommended to use oral iron preparations with
improved absorption, such as SiderAL®.
2.
The optimal treatment duration is 12 weeks, with regular monitoring of Hb, Fe, and
TSAT every 4 weeks.
3.
SiderAL® is particularly indicated for patients with low Hb (<90 g/L) and TSAT <20%,
especially when traditional iron salts are poorly tolerated.
4.
The use of SiderAL® improves treatment efficacy and may reduce the need for
erythropoiesis-stimulating agents [13,14,18].
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