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Iron Supplementation of Marginally Low Birth Weight Infants (JOHN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Umeå University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
Jerring Foundation, Sweden
Oskar Foundation
Information provided by (Responsible Party):
Magnus Domellöf, Umeå University
ClinicalTrials.gov Identifier:
NCT00558454
First received: November 14, 2007
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Anemia
Iron-Deficiency
Child Behavior Disorders
Cognitive Manifestations
Drug: Iron
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Neurological developement [ Time Frame: 6 months, 3 years and 7 years ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 380
Study Start Date: March 2004
Estimated Study Completion Date: November 2014
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   39 Days to 45 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Umeå University

Additional 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
Study First Received: November 14, 2007
Last Updated: June 4, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by 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
Child Behavior Disorders
Neurobehavioral Manifestations
Anemia
Anemia, Hypochromic
Body Weight
Hematologic Diseases
Iron Metabolism Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 25, 2014