Iron Supplementation of Marginally Low Birth Weight Infants

Anemia Clinical Trial

— JOHN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558454
• Other study ID #: Iron for LBW infants
• Status: Completed
• Phase: Phase 4
• Start date: March 2004
• Est. completion date: November 2014

Study information

• Verified date: March 2020
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: November 2014
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 39 Days to 45 Days

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Birth Weight
• Child Behavior Disorders
• Cognitive Manifestations
• Iron-Deficiency
• Mental Disorders
• Neurobehavioral Manifestations

Intervention

Drug:
• Iron
Ferrous succinate mixture

Locations

Country	Name	City	State
Sweden	Karolinska Hospital (including Danderyd Hospital)	Stockholm
Sweden	Umeå University Hospital	Umeå

Sponsors (4)

Lead Sponsor	Collaborator
Umeå University	Jerring Foundation, Sweden, Oskar Foundation, The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurological developement	6 mo: Auditory brain stem response (central conduction time) 3 y: CBCL - Parental questionnaire assessing behavioral problems and WIPPSI - test of cognitive functions 7 y: SDQ, 5-15 and CBCL - Parental questionnaires assessing behavioral problems, TeAch - test of behavioral problems and WISC - test of cognitive functions.	6 months, 3 years and 7 years
Secondary	Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)		6 months
Secondary	Growth, Iron status, and Morbidity		3 years and 7 years