Comparison of Oral Liposomal ferric pyrophosphate vs Oral ferrous sulfate in children aged 2-14years with Iron deficiency anemia

Comparison of Oral Liposomal Ferric pyrophosphate vs Oral Ferrous sulfate in children aged 2-14 years with Iron Deficiency Anemia: An Open Label Randomized Control Trial (LIFEPYSUL trial : LIposomal FErric PYrophosphate vs Ferrous SUlfate) - LIFEPYSUL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084514

Enrollment

120

Registered

2025-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Liposomal Ferric Pyrophosphate: Group A will receive oral liposomal ferric pyrophosphate Dose: 1 mg/kg/day Route of Administration : Per oral Duration : 90 days Control Intervention1

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 2-14 years with Iron deficiency anemia defined as per World Health Organization guidelines

Exclusion criteria

Exclusion criteria: 1.Children with anemia due to other etiological causes. 2.Received iron therapy in the past 3 months. 3.Children with Severe Iron Deficiency Anemia as per WHO definition will be excluded from the study

Design outcomes

Primary

Measure	Time frame
To assess the increase in hemoglobin level in children with iron deficiency anemia treated with oral liposomal ferric pyrophosphate therapy in comparison to oral ferrous sulfate therapy. Timepoint: 12weeks (90 days) after initiation of therapy in both the groups	—

Secondary

Measure	Time frame
To assess the proportion of patients with iron deficiency anemia who developed side effects on treatment with oral liposomal ferric pyrophosphate compared to oral ferrous sulfate therapyTimepoint: 12 weeks (90 days) after the initiation of therapy in both the groups	—

Countries

India

Contacts

Public ContactArun Babu T

All India Institute of Medical Sciences, Mangalagiri, Guntur, AP

pallavisamariya04@gmail.com8424064142

Outcome results