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Completed

NCT Number: NCT01216709

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

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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Key information

Conditions

Infant Dietary Supplements Food, Fortified

Age range

6 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Sciences, Pediatrics, Umeå University Hospital

Umeå, 901 85, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulfate

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 infant formula (12.4 mg iron/L)

Other

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

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

Other

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

Primary outcomes

  1. iron absorption

    Time frame: 1 month after enrollment

Secondary outcomes

  1. indicators of iron metabolism, growth, and oxidative stress

    Time frame: 1 month and 1.5 months after enrollment

  2. zinc absorption

    Time frame: 1 month after enrollment

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Swiss Federal Institute of Technology
  • University of California, Davis

Registry information

Official study title

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

Acronym: MJAU

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 7, 2010
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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