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AnemiaPhase 4JOHNNCT00558454

Iron Supplementation of Marginally Low Birth Weight Infants

A Phase 4 study testing Iron in people with Anemia and Iron-Deficiency, run by Umeå University at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 39 to 45 daysHealthy volunteers can take part
Conditions the study is for
Anemia, Iron-Deficiency, Child Behavior Disorders
What is being tested?
Iron
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
380 participants
Where
2 sitesSweden
Study dates
Mar 2004to Nov 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 39 to 45 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Marginally low birth weight (2000-2500 g)
  • Healthy at inclusion(6 weeks of age)
  • No previous blood transfusion
  • No previous iron supplementation

Who cannot join

  • Anemia at inclusion

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • Karolinska Hospital (including Danderyd Hospital)

    Stockholm

  • Umeå University Hospital

    Umeå, SE-90185

Other trials in Sweden

About this study

Official title: 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.

Being tested
Iron
Keywords
Iron supplements, Infant, Low birth weight, Prevention of iron deficiency and its physiological consequences, Safety
Medical subject headings
Anemia, Anemia, Iron-Deficiency, Child Behavior Disorders, Neurobehavioral Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IronDrug

    Also called Ferromyn S, AstraZeneca, Södertälje, Sweden

    Ferrous succinate mixture

Study groups in NCT00558454
Study groupRoleWhat they receive
1Placebo comparatorPlacebo
Receives: Drug: Iron
2Experimental1 mg/kg/day from age 6 weeks to 6 months
Receives: Drug: Iron
3Experimental2 mg/kg/day from age 6 weeks to 6 months
Receives: Drug: Iron

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months, 3 years and 7 years

Secondary outcomes (2)

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

    Measured: 6 months

  2. Growth, Iron status, and Morbidity

    Measured: 3 years and 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2007 (estimated)
  2. Study startMar 2004
  3. Primary completionJun 2008
  4. Study completionNov 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
380 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00558454
Sponsor's protocol ID
Iron for LBW infants
Acronym
JOHN
Status last verified
Mar 2020
First submitted
14 Nov 2007
Last updated
26 Mar 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28659293

  • 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.

    PubMed 26394823

  • 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.

    PubMed 25406528

  • 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.

    PubMed 25119339

  • 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.

    PubMed 23230066

  • 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.

    PubMed 22071701

  • 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.

    PubMed 20819898

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Iron in people with Anemia and Iron-Deficiency, run by Umeå University at 2 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological developement (time frame: 6 months, 3 years and 7 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558454, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.

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