JOHN: Iron Supplementation of Marginally Low Birth Weight Infants

Sponsor

Umeå University (Other)

Overall Status

Completed

CT.gov ID

NCT00558454

Collaborator

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

380

Enrollment

Locations

Arms

128

Actual Duration (Months)

190

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

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

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

Actual Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Nov 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Neurological developement [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

Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc) [6 months]
Growth, Iron status, and Morbidity [3 years and 7 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

39 Days to 45 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Hospital (including Danderyd Hospital)	Stockholm		Sweden
2	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