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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infant Dietary Supplements Food, Fortified

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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iron drops

Group Type EXPERIMENTAL

ferrous sulfate

Intervention Type DIETARY_SUPPLEMENT

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

iron-fortified formula (2.3 mg iron/L)

Group Type EXPERIMENTAL

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

Intervention Type OTHER

1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days

iron-fortified formula (12.4 mg iron /L)

Group Type EXPERIMENTAL

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

Intervention Type OTHER

6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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