NCT01216709

Iron Absorption From Infant Formula and Iron Drops in Infants (MJAU-studien)

Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 6 Months – 7 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infant
• Dietary Supplements
• Food, Fortified

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ferrous sulfate	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
OTHER	iron-fortified infant formula (12.4 mg iron/L)	6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days
OTHER	iron-fortified infant formula (2.3 mg iron/L)	1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-10-07
• Last updated: 2020-03-26

Locations

1 site across 1 country: Sweden