Iron Supplementation of Marginally Low Birth Weight Infants (JOHN)

March 25, 2020 updated by: Magnus Domellöf, Umeå University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

380

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Hospital (including Danderyd Hospital)
      • Umeå, Sweden, SE-90185
        • Umeå University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months, 3 years and 7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)
Time Frame: 6 months
6 months
Growth, Iron status, and Morbidity
Time Frame: 3 years and 7 years
3 years and 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

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

Investigators

  • Principal Investigator: Magnus Domellöf, MD, PhD, Umea university, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2004

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 14, 2007

First Posted (Estimate)

November 15, 2007

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iron for LBW infants

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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