Iron Supplementation of Marginally Low Birth Weight Infants

Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00558454

Acronym

JOHN

Enrollment

380

Registered

2007-11-15

Start date

2004-03-31

Completion date

2014-11-30

Last updated

2020-03-26

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

Conditions

Anemia, Child Behavior Disorders, Cognitive Manifestations, Iron-Deficiency

Keywords

Iron supplements, Infant, Low birth weight, Prevention of iron deficiency and its physiological consequences, Safety

Brief summary

Iron is essential for brain development and there is a well established association between iron deficiency in infants and poor neurological development. In Sweden, about 5% of newborns have low birth weight (\< 2500 g). Due to small iron stores at birth and rapid postnatal growth, they have increased risk of iron deficiency and it is therefore important to prevent iron deficiency in this population. However, excessive iron supplementation can have adverse effects in infants such as growth impairment. In a randomized, controlled trial, we are investigating the effects of 0, 1 or 2 mg/kg/d of iron on brain myelination, cognitive development and growth in low birth weight infants.

Interventions

DRUGIron

Ferrous succinate mixture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

39 Days to 45 Days

Healthy volunteers

Yes

Inclusion criteria

* Marginally low birth weight (2000-2500 g) * Healthy at inclusion(6 weeks of age) * No previous blood transfusion * No previous iron supplementation

Exclusion criteria

* Anemia at inclusion

Design outcomes

Primary

Measure	Time frame	Description
Neurological developement	6 months, 3 years and 7 years	6 mo: Auditory brain stem response (central conduction time) 3 y: CBCL - Parental questionnaire assessing behavioral problems and WIPPSI - test of cognitive functions 7 y: SDQ, 5-15 and CBCL - Parental questionnaires assessing behavioral problems, TeAch - test of behavioral problems and WISC - test of cognitive functions.

Secondary

Measure	Time frame
Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)	6 months
Growth, Iron status, and Morbidity	3 years and 7 years

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026