NCT00558454

Iron Supplementation of Marginally Low Birth Weight Infants

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 39 Days – 45 Days
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Iron	Ferrous succinate mixture

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-06-01
• Completion: 2014-11-01
• First posted: 2007-11-15
• Last updated: 2020-03-26

Locations

2 sites across 1 country: Sweden