Overview

This trial is active, not recruiting.

Conditions anemia, iron-deficiency, child behavior disorders, cognitive manifestations
Treatment iron
Phase phase 4
Sponsor Umeå University
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Placebo Comparator)
Placebo
iron Ferromyn S, AstraZeneca, Södertälje, Sweden
Ferrous succinate mixture
(Experimental)
1 mg/kg/day from age 6 weeks to 6 months
iron Ferromyn S, AstraZeneca, Södertälje, Sweden
Ferrous succinate mixture
(Experimental)
2 mg/kg/day from age 6 weeks to 6 months
iron Ferromyn S, AstraZeneca, Södertälje, Sweden
Ferrous succinate mixture

Primary Outcomes

Measure
Neurological developement
time frame: 6 months, 3 years and 7 years

Secondary Outcomes

Measure
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

Eligibility Criteria

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

Additional Information

Official title Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g
Principal investigator Magnus Domellöf, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Umeå University.