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Iron Supplementation of Marginally Low Birth Weight Infants (JOHN)

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ClinicalTrials.gov Identifier: NCT00558454
Recruitment Status : Unknown
Verified June 2012 by Magnus Domellöf, Umeå University.
Recruitment status was:  Active, not recruiting
First Posted : November 15, 2007
Last Update Posted : June 5, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Anemia Iron-Deficiency Child Behavior Disorders Cognitive Manifestations Drug: Iron Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g
Study Start Date : March 2004
Primary Completion Date : June 2008
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Placebo
Drug: Iron
Ferrous succinate mixture
Other Name: Ferromyn S, AstraZeneca, Södertälje, Sweden
Experimental: 2
1 mg/kg/day from age 6 weeks to 6 months
Drug: Iron
Ferrous succinate mixture
Other Name: Ferromyn S, AstraZeneca, Södertälje, Sweden
Experimental: 3
2 mg/kg/day from age 6 weeks to 6 months
Drug: Iron
Ferrous succinate mixture
Other Name: Ferromyn S, AstraZeneca, Södertälje, Sweden


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   39 Days to 45 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00558454


Locations
Sweden
Karolinska Hospital (including Danderyd Hospital)
Stockholm, Sweden
Umeå University Hospital
Umeå, Sweden, SE-90185
Sponsors and Collaborators
Umeå University
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Jerring Foundation, Sweden
Oskar Foundation
Investigators
Principal Investigator: Magnus Domellöf, MD, PhD Umeå University, Sweden
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Magnus Domellöf, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT00558454     History of Changes
Other Study ID Numbers: Iron for LBW infants
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: June 5, 2012
Last Verified: June 2012

Keywords provided by Magnus Domellöf, Umeå University:
Iron supplements
Infant
Low birth weight
Prevention of iron deficiency and its physiological consequences
Safety

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Birth Weight
Mental Disorders
Child Behavior Disorders
Neurobehavioral Manifestations
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Body Weight
Signs and Symptoms
Neurodevelopmental Disorders
Neurologic Manifestations
Nervous System Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs