Iron Supplementation of Marginally Low Birth Weight Infants

NCT00558454 | Completed Phase 4 DMC

• 1 other identifier: Iron for LBW infants
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months, 3 years and 7 years

Secondary Outcomes (2)

• 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

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Drug: Iron

2

EXPERIMENTAL

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

Drug: Iron

3

EXPERIMENTAL

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

Drug: Iron

Interventions

Iron DRUG

Ferrous succinate mixture

Also known as: Ferromyn S, AstraZeneca, Södertälje, Sweden

1; 2; 3

Eligibility Criteria

• Age: 39 Days - 45 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Marginally low birth weight (2000-2500 g)
• No previous blood transfusion
• No previous iron supplementation

Sponsors & Collaborators

• Umeå University: lead
• The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS): collaborator
• Jerring Foundation, Sweden: collaborator
• Oskar Foundation: collaborator

Study Sites (2)

Karolinska Hospital (including Danderyd Hospital)

Stockholm, Sweden

Location

Umeå University Hospital

Umeå, SE-90185, Sweden

Location

Related Publications (7)

• 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.

  PMID: 28659293 DERIVED

• 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.

  PMID: 26394823 DERIVED

• 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.

  PMID: 25406528 DERIVED

• 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.

  PMID: 25119339 DERIVED

• 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.

  PMID: 23230066 DERIVED

• 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.

  PMID: 22071701 DERIVED

• 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.

  PMID: 20819898 DERIVED

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency; Child Behavior Disorders; Neurobehavioral Manifestations

Interventions

Iron

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurodevelopmental Disorders; Mental Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Magnus Domellöf, MD, PhD

  Umeå University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: March 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: November 1, 2014
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

SE (2)