A Phase 4 interventional study of Iron in Anemia, Iron-Deficiency and Child Behavior Disorders, sponsored by Umeå University. Completed at 2 sites in Sweden. Open to participants aged 39 Days to 45 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Umeå University · Phase 4, Interventional, and Prevention
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.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
This study's enrollment of 380 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Browse Anemia studies →Umeå University is the lead sponsor of 272 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
Placebo
Drug: Iron
1 mg/kg/day from age 6 weeks to 6 months
Drug: Iron
2 mg/kg/day from age 6 weeks to 6 months
Drug: Iron
Ferrous succinate mixture
Also known as: Ferromyn S, AstraZeneca, Södertälje, Sweden
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.
Time frame: 6 months, 3 years and 7 years
Growth (weight, length, head circumference, knee-heel length), Morbidity and Iron status (Hemoglobin, ferritin etc)
Time frame: 6 months
Growth, Iron status, and Morbidity
Time frame: 3 years and 7 years
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iron