Clinical trial NCT00558454: Iron Supplementation of Marginally Low Birth Weight Infants
Official title: Randomized, Controlled Study of Iron Supplementation of Infants With Birth Weights 2000-2500 g
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
name: Jerring Foundation, Sweden
name: Oskar Foundation
First posted: 2007-11-15
Enrollment: 380
Sex: ALL
Minimum age (years): 39
Maximum age (years): 45
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Neurological developement
timeFrame: 6 months, 3 years and 7 years
Secondary outcomes:
measure: Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)
timeFrame: 6 months
measure: Growth, Iron status, and Morbidity
timeFrame: 3 years and 7 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Hospital (including Danderyd Hospital)
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University, Sweden
name: Magnus Domellöf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.