Comparison of the effectiveness of liposomal and ferrous iron in the treatment of iron deficiency in infants and children

With due attention to the importance and serious complications of iron deficiency and the need to treat it and find an easy method in children with maximum effectiveness, this clinical trial is conducted to compare the effectiveness of liposomal iron with previous formulations in children with iron deficiency.

In a randomized, double-blind clinical trial, phase 4, children at 6 months to 2 years of age will be enrolled in the study. Infants with iron deficiency will be randomly assigned to two groups by simple lottery method.

Children between 6 months to 2 years of age with iron deficiency who referr to the pediatrics clinic at Amir Al-Momenin hospital or maternal and child health care centers of Semnan will be randomly assigned to two groups, the first group will receive liposomal iron and the second group will receive ferrous supplements. A complete blood cell count and measurement of iron, ferritin and TIBC levels are performed before the intervention and at the end of the fourth and twelfth weeks after intervention and at the end of the twelfth week, the occurrence of any side effects after intervention will be recorded.

Inclusion criteria: infants with iron deficiency. Non-inclusion criteria: history of taking iron supplements; hemoglobinopathy; severe anemia; asthma; malignancy; active infection; renal dysfunction.

Intervention group: the first group receives liposomal iron equivalent to 6 mg of elemental iron per kilogram of body weight, at a maximum dose of 200 mg daily. Control group: the second group receives ferrous iron equivalent to 6 mg of elemental iron per kilogram of body weight, at a maximum dose of 200 mg daily.

The main outcome variables are included changes in hematology index, hemoglobin, hematocrit, iron , ferritin and TIBC levels.

For randomization, at first stage, 60 spheres from one to 60 are considered and following that will randomly divided into two equal parts, including "1" (Intervention1) and group 2 (Intervention2), and then using a lottery container, the ball of each group taken out and the intended sequence will be recorded.

The blinding of the study is such that the care provider, outcome assessor and biostatistician do not know the content of the intervention. For administration, the drug will be given to the clinical care provider for administration by mentioning the administration method. The outcome assessor records the outcome based on the patient's identity number according to the randomization table, and the data collected based on the number and mention of the first and second intervention is provided to the biostatistician for analysis.

All data will be presented anonymously.

After publishing of the results, the data will be delivered upon request and after verification.

The data will be available only for academic researchers.

In order to conduct similar studies.

Direct request from the scientific responsible.

After request and authentication, the data will be provided.