Iron Supplementation of Marginally Low Birth Weight Infants (JOHN)

Umeå University

Status and phase: Completed; Phase 4

Conditions: Iron-Deficiency; Anemia; Cognitive Manifestations; Child Behavior Disorders

Treatments: Drug: Iron

Study type: Interventional

Funder types: Other

Identifiers

NCT00558454

Iron for LBW infants

Details and patient eligibility

About

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.

Enrollment: 380 patients

Sex: All

Ages: 39 to 45 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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380 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Iron

2

Experimental group

Description:

1 mg/kg/day from age 6 weeks to 6 months

Treatment:

Drug: Iron

3

Experimental group

Description:

2 mg/kg/day from age 6 weeks to 6 months

Treatment:

Drug: Iron