Iron Supplementation of Marginally Low Birth Weight Infants
This trial is active, not recruiting.
|Conditions||anemia, iron-deficiency, child behavior disorders, cognitive manifestations|
|Collaborator||The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)|
|Start date||March 2004|
|End date||June 2008|
|Trial size||380 participants|
|Trial identifier||NCT00558454, Iron for LBW infants|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: 6 months, 3 years and 7 years
Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)
time frame: 6 months
Growth, Iron status, and Morbidity
time frame: 3 years and 7 years
Male or female participants from 39 days up to 45 days old.
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
|Official title||Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g|
|Principal investigator||Magnus Domellöf, MD, PhD|
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