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Iron Supplementation of Marginally Low Birth Weight Infants

NCT00558454 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2020-03-26

No results posted yet for this study

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

DRUG

Iron

Ferrous succinate mixture

Sponsors & Collaborators

  • The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

    collaborator OTHER_GOV

  • Jerring Foundation, Sweden

    collaborator UNKNOWN

  • Oskar Foundation

    collaborator OTHER

  • Umeå University

    lead OTHER

Principal Investigators

  • Magnus Domellöf, MD, PhD · Umeå University, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
39 Days
Max Age
45 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-06-30
Completion
2014-11-30

Countries

  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00558454 on ClinicalTrials.gov