Iron Boost for Healthy Babies: Examining Anemia Improvement at 6 Months vs. 4 Months

Evaluation of Efficacy of Initiating Daily Iron Supplementation at 1-2 mg/kg/day at 4 Months of Age in Term, Healthy Infants in Reducing Incidence of Iron Deficiency/Iron Deficiency Anemia at 6 Months of Age as Compared to Placebo - A Single Centre, Triple-Blinded, Randomised Controlled Trial - TrIS

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060754

Enrollment

208

Registered

2023-12-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

None listed

Interventions

Intervention1: Iron Supplementation: Irofin XT drops (ferrous fumarate, containing elemental iron 10 mg/ml) at 1-2 mg/kg/day for 2 months Control Intervention1: Excipient: 1 ml of excipient for 2 mont

Eligibility

Inclusion criteria

Inclusion criteria: Term ( > 37 weeks of period of gestation), healthy infats with Hb > 11 g/dl, Birth weight >2.5 kg, Appropriate for gestational Age, fulfilling Delayed cord clamping (DCC, after minimum 1 minute), those parents who are motivated and willing to stay in vicinity of AIIMS Patna and complete the study including follow up

Exclusion criteria

Exclusion criteria: Mothers with Antepartum Hemorrhage, Bleeding in newborn, Hemolytic disease in newborn (immune/non immune), h/o NICU admission in view of sepsis/ need of inotropic support/ mechanical ventilation/ PRBC transfusion, Maternal age <20 years

Design outcomes

Primary

Measure	Time frame
1. To determine incidence of Iron deficiency anemia compared to placebo 2. To determine prevalence of iron deficiency compared to placebo using concurrent serum ferritin & CRP values.Timepoint: 6 months of age	—

Secondary

Measure	Time frame
1. To determine Reticulocyte hemoglobin equivalent 2. To compare MCV levels between two groups 3. To compare anthropometric measurementsTimepoint: 6 months of age	—

Countries

India

Contacts

Public ContactDr Chandra Mohan Kumar

All India Institute of Medical Sciences, Patna

cmkumar@aiimspatna.org8368537792

Outcome results