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OpenTrials
Completed

NCT Number: NCT00558454

Iron Supplementation of Marginally Low Birth Weight 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.

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Key information

Conditions

Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Child Behavior Disorders Cognitive Manifestations Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Iron-deficiency Mental Disorders Metabolic Diseases Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

39 day–45 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karolinska Hospital (including Danderyd Hospital), Stockholm, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iron

Drug

Ferrous succinate mixture

Other names: Ferromyn S, AstraZeneca, Södertälje, Sweden

Primary outcomes

  1. Neurological developement

    Time frame: 6 months, 3 years and 7 years

    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.

Secondary outcomes

  1. Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)

    Time frame: 6 months

  2. Growth, Iron status, and Morbidity

    Time frame: 3 years and 7 years

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: JOHN

Important dates

Study start
2004
Primary completion
2008
Study completion
2014
First posted
Nov 15, 2007
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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