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

Not Applicable

Completed

• Conditions: Infant; Food, Fortified; Dietary Supplements
• Interventions: Dietary Supplement: ferrous sulfate; Other: iron-fortified infant formula (12.4 mg iron/L); Other: iron-fortified infant formula (2.3 mg iron/L)

• Registration Number: NCT01216709
• Lead Sponsor: Umeå University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iron drops	ferrous sulfate	-
iron-fortified formula (12.4 mg iron /L)	iron-fortified infant formula (12.4 mg iron/L)	-
iron-fortified formula (2.3 mg iron/L)	iron-fortified infant formula (2.3 mg iron/L)	-

Primary Outcome Measures

Name	Time	Method
iron absorption	1 month after enrollment

Secondary Outcome Measures

Name	Time	Method
indicators of iron metabolism, growth, and oxidative stress	1 month and 1.5 months after enrollment
zinc absorption	1 month after enrollment

Trial Locations

Locations (1)

Department of Clinical Sciences, Pediatrics, Umeå University Hospital; 🇸🇪 Umeå, Sweden