A Study to Compare Liposomal Iron With Ferrous Ascorbate in the Treatment of Iron Deficiency Anemia in Children

Summary

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.

Conditions

• Nutritional Anemia

Interventions

DRUG

Ferric Pyrophosphate Liposomal

Liposomal iron, a form of ferric pyrophosphate is transported within a phospholipid membrane, absorbed by the intestinal M cells, reaches to the liver directly through lymphatics and finally released. Due to this mechanism, liposomal iron has been reported to have better bioavailability than traditional iron preparations thus requiring lesser dose and producing fewer adverse effects The group would be given liposomal iron syrup at a dose of 1mg per kg per day once a day for 3 months

DRUG

ferrous ascorbate

one of the most commonly used forms of iron syrup in children. The group would be given ferrous ascorbate syrup at a dose of 3mg per kg per day once a day for 3 months

Sponsors & Collaborators

• All India Institute of Medical Sciences

  lead OTHER

Principal Investigators

• Namita Mishra, MDPediatrics · AIIMS Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-31

Primary Completion

2024-08-31

Completion

2025-02-28

Countries

• India

Study Locations