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

Study Overview
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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.

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

Conditions
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Infant, Dietary Supplements, Food, Fortified

Intervention / Treatment
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* Dietary Supplement: ferrous sulfate
* Other: iron-fortified infant formula (12.4 mg iron/L)
* Other: iron-fortified infant formula (2.3 mg iron/L)


Participation Criteria
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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 Exclusion Criteria: iron deficiency at enrollment previous or current use of iron supplements

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iron drops<br> | Dietary Supplement: ferrous sulfate<br>* 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<br>|
| Experimental: iron-fortified formula (2.3 mg iron/L)<br> | Other: iron-fortified infant formula (2.3 mg iron/L)<br>* 1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days<br>|
| Experimental: iron-fortified formula (12.4 mg iron /L)<br> | Other: iron-fortified infant formula (12.4 mg iron/L)<br>* 6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iron absorption |  | 1 month after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| indicators of iron metabolism, growth, and oxidative stress |  | 1 month and 1.5 months after enrollment | 
| zinc absorption |  | 1 month after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Dietary Supplements, Food, Fortified, Iron Absorption