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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01216709

Acronym

MJAU

Enrollment

Registered

2010-10-07

Start date

2010-10-31

Completion date

2012-06-30

Last updated

2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dietary Supplements, Food, Fortified, Infant

Keywords

Infant, Dietary Supplements, Food, Fortified, Iron Absorption

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.

Interventions

DIETARY_SUPPLEMENTferrous 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

OTHERiron-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

OTHERiron-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 7 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
iron absorption	1 month after enrollment

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026