An interventional study of ferrous sulfate and iron-fortified infant formula (12.4 mg iron/L) in Infant, Dietary Supplements and Food, Fortified, sponsored by Umeå University. Completed at 1 site in Sweden. Open to participants aged 6 Months to 7 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Umeå University · Not applicable, Interventional, and Basic science
Iron deficiency (ID) affects up to 25% of Swedish infants and severe ID is associated with cognitive and behavioral problems. To avoid this, iron supplements or iron-fortified infant foods are recommended for infants. However, the optimal iron dose and mode of delivery have not yet been established. This is a concern as excessive iron intake may impair growth and increase morbidity in iron-sufficient infants. Previous studies have suggested that iron-fortified foods may have different effects than iron supplements. In this study, the investigators will investigate whether the mode of iron administration (supplementation vs. fortification) and the amount consumed (high intakes vs. low intakes) affect iron absorption, iron utilization, and zinc absorption in healthy term non-iron-deficient 6-month-old infants.
Umeå University is the lead sponsor of 263 studies on the registry; 60 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: ferrous sulfate
Other: iron-fortified infant formula (2.3 mg iron/L)
Other: iron-fortified infant formula (12.4 mg iron/L)
6.3 mg iron from iron drops and 0.3 mg iron from infant formula with no added iron (0.5 mg iron/L) for 45 days
6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days
1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days
iron absorption
Time frame: 1 month after enrollment
indicators of iron metabolism, growth, and oxidative stress
Time frame: 1 month and 1.5 months after enrollment
zinc absorption
Time frame: 1 month after enrollment
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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Umeå University