Trial | NCT00558454  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    380
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.
Study Started
Mar 31
2004
Primary Completion
Jun 30
2008
Study Completion
Nov 30
2014
Last Update
Mar 26
2020

Drug Iron

Ferrous succinate mixture

  • Other names: Ferromyn S, AstraZeneca, Södertälje, Sweden

1 Placebo Comparator

Placebo

2 Experimental

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

3 Experimental

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

Criteria 

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
No Results Posted