Lactoferrin versus iron hydroxide polymaltose complex for the treatment of iron deficiency anemia in children with cerebral palsy: a randomized controlled trial.

2021-05-28
European journal of pediatrics 180(8)
- Omneya M Omar
- Hala Assem
- Doaa Ahmed
- Marwa S Abd Elmaksoud

PubMed: 34101010
DOI: 10.1007/s00431-021-04125-9

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 70
Population: 70 children aged 1-10 years with cerebral palsy and iron deficiency anemia
Methods: Randomized controlled study, 35 children received iron hydroxide polymaltose complex (IPC) and 35 received lactoferrin
Blinding: Open-label
Duration: 4 weeks
Funding: Unclear

Iron deficiency anemia (IDA) is common among children with cerebral palsy (CP), and studies on the efficacy of lactoferrin (Lf) in the treatment of IDA are limited. This study aimed to compare the efficacy of Lf with that of iron hydroxide polymaltose complex (IPC) in the treatment of IDA in children with CP. This randomized controlled study, conducted at Alexandria University Children's Hospital, enrolled 70 children aged 1-10 years with CP and IDA; 35 children randomly received IPC, whereas the other 35 received Lf. Four children withdrew from the study; thus, only 66 children were analyzed (32 in the IPC group and 34 in the Lf group). At baseline, the hemoglobin level and other blood parameters were similar between the two intervention groups. After four weeks of treatment, both the IPC and Lf groups showed significant improvements in hemoglobin (Hb), serum ferritin (SF), serum iron, total iron-binding capacity, mean corpuscular volume, and mean corpuscular hemoglobin from baseline. Upon comparing the two treatment groups, adjusted mean Hb and SF changes in the Lf group were significantly higher than that of the IPC group (p =0.001and p= 0.033, respectively), and constipation was less likely to occur in the Lf group than the IPC group (p = 0.049 ).Conclusion: Lactoferrin is effective and superior to IPC as an oral iron replacement therapy in children with CP and IDA, as it has fewer side effects. What is Known: • Lactoferrin (LF) is a natural glycoprotein capable of treating iron deficiency anemia (IDA). • Studies on the efficacy of Lf in the treatment of IDA in children with cerebral palsy (CP) are limited. What is New? • This trial compared the efficacy of Lf and iron hydroxide polymaltose complex (IPC) as treatments of IDA in children with CP. • Lf is effective and even better than IPC as a treatment of IDA in children with CP, as it has fewer side effects.

Research Insights

Lactoferrin→Increased Hemoglobin Levels
Upon comparing the two treatment groups, adjusted mean Hb and SF changes in the Lf group were significantly higher than that of the IPC group (p =0.001and p= 0.033, respectively)
Effect
Beneficial
Effect size
Small
Lactoferrin→Increased Mean Corpuscular Hemoglobin Level
After four weeks of treatment, both the IPC and Lf groups showed significant improvements in hemoglobin (Hb), serum ferritin (SF), serum iron, total iron-binding capacity, mean corpuscular volume, and mean corpuscular hemoglobin from baseline.
Effect
Neutral
Effect size
Small
Lactoferrin→Increased Mean Corpuscular Volume
After four weeks of treatment, both the IPC and Lf groups showed significant improvements in hemoglobin (Hb), serum ferritin (SF), serum iron, total iron-binding capacity, mean corpuscular volume, and mean corpuscular hemoglobin from baseline.
Effect
Neutral
Effect size
Small
Lactoferrin→Increased Serum Ferritin Level
Upon comparing the two treatment groups, adjusted mean Hb and SF changes in the Lf group were significantly higher than that of the IPC group (p =0.001and p= 0.033, respectively)
Effect
Beneficial
Effect size
Small
Lactoferrin→Increased Serum Iron Level
After four weeks of treatment, both the IPC and Lf groups showed significant improvements in hemoglobin (Hb), serum ferritin (SF), serum iron, total iron-binding capacity, mean corpuscular volume, and mean corpuscular hemoglobin from baseline.
Effect
Neutral
Effect size
Small
Lactoferrin→Reduced Total Iron-Binding Capacity
After four weeks of treatment, both the IPC and Lf groups showed significant improvements in hemoglobin (Hb), serum ferritin (SF), serum iron, total iron-binding capacity, mean corpuscular volume, and mean corpuscular hemoglobin from baseline.
Effect
Neutral
Effect size
Small

Adverse Events Reported

Lactoferrin→constipation
constipation was less likely to occur in the Lf group than the IPC group (p = 0.049)
Finding
Increased risk
Significant
Yes
Lactoferrin→constipation
constipation was less likely to occur in the Lf group than the IPC group (p = 0.049)
Finding
Reported
Magnitude
p = 0.049
Significant
Yes