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

Umeå University

Status: Completed

Conditions: Food, Fortified; Infant; Dietary Supplements

Treatments: Dietary Supplement: ferrous sulfate; Other: iron-fortified infant formula (2.3 mg iron/L); Other: iron-fortified infant formula (12.4 mg iron/L)

Study type: Interventional

Funder types: Other

Identifiers

NCT01216709

Iron absorption in infants

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 6 to 7 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 3 patient groups

iron drops

Experimental group

Treatment:

Dietary Supplement: ferrous sulfate

iron-fortified formula (2.3 mg iron/L)

Experimental group

Treatment:

Other: iron-fortified infant formula (2.3 mg iron/L)

iron-fortified formula (12.4 mg iron /L)

Experimental group

Treatment:

Other: iron-fortified infant formula (12.4 mg iron/L)