Effect of Ferrous Ascorbate Versus Liposomal Iron on Hemoglobin Concentration and Iron Indices in 6 to 59 Months Age Children With Nutritional Iron-Deficiency Anemia: A Double-blinded Single Centre Randomized Clinical Trial

AIIMS/RBL/IRC/69/2022

This trial is designed to compare the efficacy of ferrous ascorbate versus liposomal iron for the treatment of nutritional iron deficiency anemia (IDA) amongst 6 to 59 months age children as determined by the increase in hemoglobin concentration and change in iron indices after 12 weeks of treatment. This study will be a randomized double-blinded single-center study done at the outpatient department of the Department of Pediatrics. All the children between 6 months to 59 months with nutritional IDA will be enrolled in the study. Written informed consent will be taken from the caregiver. At baseline detailed history will be taken and a complete physical examination will be done. Complete blood count (CBC), Peripheral smear, corrected reticulocyte count, Serum iron, Serum ferritin, and serum Total iron binding capacity(TIBC) will be done at baseline. Transferrin saturation will be calculated with the formula Serum Iron/ TIBC ×100. C Reactive Protein (CRP) and alpha1- acid glycoprotein (AGP) will be done to look for inflammation. Eligible subjects would be randomized in a 1:1 ratio by computerized software to receive either ferrous ascorbate or liposomal iron. Subjects in the ferrous ascorbate group would be given the drug at a dose of 3mg/kg/day OD of elemental iron. Subjects in the liposomal group would be given 1mg/kg/day OD of liposomal iron. Follow-up visits would be done at 4 and 12 weeks. Follow-up at 4 weeks is required to check the initial response to treatment and identify nonresponders and at 12 weeks is required to see the final response and thus decide upon continuation or discontinuation of treatment. In the follow-up visit at 4 and 12 weeks, CBC, Iron profile (Iron, Ferritin, and TIBC), CRP, and AGP will be done. Corrected Reticulocyte will be done at 4 weeks only. Any adverse effects of therapy will be noted. Adherence to therapy will be checked by measuring the volume of unused medicine in the bottle at each visit. All the statistically analyzed continuous data will be presented as mean ± standard deviation (SD). The categorical data will be reported as a percentage. Student's t-tests will be used to compare means. The χ2 test will be used to compare categorical outcomes, including the proportion of patients with dropouts, adverse effects, and adherence measures. The percentage volume of unused study medication returned at each visit will be compared using the Wilcoxon rank sign test. p\<0.05 will be considered statistically significant.

2023-08-01

2024-08-01

2025-02-01

Not yet recruiting

Early phase I

96

Inclusion Criteria: Children in the age group 6 to 59 months with Nutritional Iron Deficiency Anaemia as confirmed by hematological parameters Exclusion Criteria: 1. Subjects with other causes of anemia(hemolytic anemia, bone marrow failure) as evidenced by clinical symptoms and signs and or laboratory values 2. Subjects with ongoing blood loss 3. Subjects who have received any iron therapy or blood transfusion in the past 3 months 4. Subjects with disease interfering with iron absorption e.g. Inflammatory bowel disease, celiac disease, bowel surgery, chronic gastrointestinal infection 5. Subjects with serious chronic medical conditions like chronic kidney disease, congenital heart disease, and chronic lung disease. 6. Subjects with prior history of allergy to iron preparations

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2023-07-24