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

Infant Clinical Trial

— MJAU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216709
• Other study ID #: Iron absorption in infants
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2020
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 7 Months

Eligibility

Inclusion Criteria:

• 6-7 months of age at the start of intervention

• healthy at enrollment

• full-term (>37 gestational weeks at birth)

• birth weight >2500 g

• predominantly bottle-fed at recruitment

Exclusion Criteria:

• iron deficiency at enrollment

• previous or current use of iron supplements

Related Conditions & MeSH terms

• Dietary Supplements
• Food, Fortified
• Infant

Intervention

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
• 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

Locations

Country	Name	City	State
Sweden	Department of Clinical Sciences, Pediatrics, Umeå University Hospital	Umeå

Sponsors (3)

Lead Sponsor	Collaborator
Umeå University	Swiss Federal Institute of Technology, University of California, Davis

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	iron absorption		1 month after enrollment
Secondary	indicators of iron metabolism, growth, and oxidative stress		1 month and 1.5 months after enrollment
Secondary	zinc absorption		1 month after enrollment