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Iron Supplementation of Marginally Low Birth Weight Infants (JOHN)

Primary Purpose

Anemia, Iron-Deficiency, Child Behavior Disorders

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Iron

About this trial

This is an interventional prevention trial for Anemia focused on measuring Iron supplements, Infant, Low birth weight, Prevention of iron deficiency and its physiological consequences, Safety

Eligibility Criteria

39 Days - 45 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Karolinska Hospital (including Danderyd Hospital)
Umeå University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo

1 mg/kg/day from age 6 weeks to 6 months

2 mg/kg/day from age 6 weeks to 6 months

Outcomes

Primary Outcome Measures

Neurological developement

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)

Growth, Iron status, and Morbidity

Full Information

NCT ID

NCT00558454

First Posted

November 14, 2007

Last Updated

March 25, 2020

Sponsor

Umeå University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00558454

Brief Title

Iron Supplementation of Marginally Low Birth Weight Infants

Acronym

JOHN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

March 2004 (Actual)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Umeå University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Iron-Deficiency, Child Behavior Disorders, Cognitive Manifestations

Keywords

Iron supplements, Infant, Low birth weight, Prevention of iron deficiency and its physiological consequences, Safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

380 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Arm Type

Experimental

Arm Description

1 mg/kg/day from age 6 weeks to 6 months

Arm Title

Arm Type

Experimental

Arm Description

2 mg/kg/day from age 6 weeks to 6 months

Intervention Type

Drug

Intervention Name(s)

Iron

Other Intervention Name(s)

Ferromyn S, AstraZeneca, Södertälje, Sweden

Intervention Description

Ferrous succinate mixture

Primary Outcome Measure Information:

Title

Neurological developement

Description

Time Frame

6 months, 3 years and 7 years

Secondary Outcome Measure Information:

Title

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

Time Frame

6 months

Title

Growth, Iron status, and Morbidity

Time Frame

3 years and 7 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

39 Days

Maximum Age & Unit of Time

45 Days

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magnus Domellöf, MD, PhD

Organizational Affiliation

Umeå University, Sweden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska Hospital (including Danderyd Hospital)

City

Stockholm

Country

Sweden

Facility Name

Umeå University Hospital

City

Umeå

ZIP/Postal Code

SE-90185

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

28659293

Citation

Lindberg J, Norman M, Westrup B, Domellof M, Berglund SK. Lower systolic blood pressure at age 7 y in low-birth-weight children who received iron supplements in infancy: results from a randomized controlled trial. Am J Clin Nutr. 2017 Aug;106(2):475-480. doi: 10.3945/ajcn.116.150482. Epub 2017 Jun 28.

Results Reference

derived

PubMed Identifier

26394823

Citation

Lindberg J, Norman M, Westrup B, Ohrman T, Domellof M, Berglund SK. Overweight, Obesity, and Body Composition in 3.5- and 7-Year-Old Swedish Children Born with Marginally Low Birth Weight. J Pediatr. 2015 Dec;167(6):1246-52.e3. doi: 10.1016/j.jpeds.2015.08.045. Epub 2015 Sep 26.

Results Reference

derived

PubMed Identifier

25406528

Citation

Berglund SK, Westrup B, Domellof M. Iron supplementation until 6 months protects marginally low-birth-weight infants from iron deficiency during their first year of life. J Pediatr Gastroenterol Nutr. 2015 Mar;60(3):390-5. doi: 10.1097/MPG.0000000000000633.

Results Reference

derived

PubMed Identifier

25119339

Citation

Berglund SK, Lindberg J, Westrup B, Domellof M. Effects of iron supplements and perinatal factors on fetal hemoglobin disappearance in LBW infants. Pediatr Res. 2014 Nov;76(5):477-82. doi: 10.1038/pr.2014.116. Epub 2014 Aug 13.

Results Reference

derived

PubMed Identifier

23230066

Citation

Berglund SK, Westrup B, Hagglof B, Hernell O, Domellof M. Effects of iron supplementation of LBW infants on cognition and behavior at 3 years. Pediatrics. 2013 Jan;131(1):47-55. doi: 10.1542/peds.2012-0989. Epub 2012 Dec 10.

Results Reference

derived

PubMed Identifier

22071701

Citation

Berglund S, Lonnerdal B, Westrup B, Domellof M. Effects of iron supplementation on serum hepcidin and serum erythropoietin in low-birth-weight infants. Am J Clin Nutr. 2011 Dec;94(6):1553-61. doi: 10.3945/ajcn.111.013938. Epub 2011 Nov 9.

Results Reference

derived

PubMed Identifier

20819898

Citation

Berglund S, Westrup B, Domellof M. Iron supplements reduce the risk of iron deficiency anemia in marginally low birth weight infants. Pediatrics. 2010 Oct;126(4):e874-83. doi: 10.1542/peds.2009-3624. Epub 2010 Sep 6.

Results Reference

derived

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Iron Supplementation of Marginally Low Birth Weight Infants

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