Comparison of two oral iron formulation in preterm infants

Comparative efficacy of oral liposomal iron vs oral colloidal iron (standard care) in improving iron status in preterm infants of gestational age 30 to 34 weeks - A Double blind randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082342

Enrollment

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: D509- Iron deficiency anemia, unspecified

Interventions

Intervention1: Liposomal oral iron formulation: Liposoml iron at a dose of 3mg/kg/day per oral once daily for 2 months started after 2 weeks of birth.they are followed up after 4 weeks and 8 weeks aft

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants of gestational age 30-34 weeks On exclusive breast feeding On full enteral nutrition

Exclusion criteria

Exclusion criteria: Preterm who had Blood transfusions Congenital gastrointestinal malformations Necrotising enterocolitis

Design outcomes

Primary

Measure	Time frame
To assess change in serum ferritin levelTimepoint: To assess change in serum ferritin level of baseline and at 4 weeks and 8 weeks after iron supplementation	—

Secondary

Measure	Time frame
1.To assess increase in hemoglobin levels 2.Assess pattern of weight gain 3.To determine the gastrointestinal side effects oral iron therapyTimepoint: 2 months	—

Countries

India

Contacts

Public ContactNivas

Madras medical college

drmangalabharathi@gmail.com9840786836

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026