Iron Supplementation of Marginally Low Birth Weight Infants (JOHN)

This study is ongoing, but not recruiting participants.

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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 14, 2007

Last Updated Date

June 4, 2012

Start Date ^ICMJE

March 2004

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Auditory brain stem response (central conduction time) [ Time Frame: 6 months ]

Change History

Complete list of historical versions of study NCT00558454 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc) [ Time Frame: 6 months ]
Cognitive development (WPPSI-III) Growth Iron status [ Time Frame: 3 years ]
Cognitive development Growth Iron status [ Time Frame: 7 years ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Iron Supplementation of Marginally Low Birth Weight Infants

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Anemia
Iron-Deficiency
Child Behavior Disorders
Cognitive Manifestations

Intervention ^ICMJE

Drug: Iron

Ferrous succinate mixture

Other Name: Ferromyn S, AstraZeneca, Södertälje, Sweden

Study Arm (s)

Placebo Comparator: 1
Placebo

Intervention: Drug: Iron
Experimental: 2
1 mg/kg/day from age 6 weeks to 6 months

Intervention: Drug: Iron
Experimental: 3
2 mg/kg/day from age 6 weeks to 6 months

Intervention: Drug: Iron

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

380

Estimated Completion Date

November 2014

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

39 Days to 45 Days

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00558454

Other Study ID Numbers ^ICMJE

Iron for LBW infants

Has Data Monitoring Committee

Yes

Responsible Party

Magnus Domellöf, Umeå University

Study Sponsor ^ICMJE

Umeå University

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Magnus Domellöf, MD, PhD

Umeå University, Sweden

Information Provided By

Umeå University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top