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Assessment of the effect of early vs routine Iron Supplementation on iron store and growth in term infants at 1 year

A randomized controlled trial to assess the effect of early vs routine Iron Supplementation on iron store and growth in term small for gestational age (SGA) and appropriate for gestational age (AGA) infants at 1 year

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009904
Enrollment
300
Registered
2017-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Term well infants at 6 weeks

Interventions

Intervention1: Oral iron supplementation: Oral iron supplementation @ 2mg/kg/day from 6 weeks to 1 year in the study group and from 6 months in the control group Control Intervention1: Iron supplement

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Term infants (born after 37 completed weeks of gestation by USG dating or LMP whichever applicable) 2. Appropriate for gestational age (as per revised Fentonâ??s chart 2013) 3. Small for gestational age (birth weight 4. Parents consenting to follow up till 1 year 5. Parents residing within 100 kilometres of Chandigarh

Exclusion criteria

Exclusion criteria: 1. H/o blood product transfusion prior to study enrolment 2. Severe birth asphyxia defined as 1 minute Apgar score 0-3 with or without mod to severe HIE 3. Severe sepsis with septic shock 4. Suspect haematological disorders (haemolytic jaundice, Rh isoimmunisation) 5. Infants with chronic diseases like congenital heart disease, cholestatic jaundice and suspected liver disease, suspected or diagnosed renal tubular acidosis, suspected or diagnosed inborn errors of metabolism 6. Suspected or proven chromosomal abnormalities.

Design outcomes

Primary

MeasureTime frame
1. Proportion of infants with Iron Deficiency Anemia. at 6 months and 1 year in 2 groupsTimepoint: 1. Proportion of infants with Iron Deficiency Anemia. at 6 months and 1 year in 2 groups

Secondary

MeasureTime frame
Growth in terms of height (in cm), weight (in kg) and OFC (in cm)Timepoint: 6 months and 1 year

Countries

India

Contacts

Public ContactDeepanjan Bhattacharya

PGIMER Chandigarh

kanyapgi@gmail.com

Outcome results

None listed

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