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

March 25, 2020 updated by: Magnus Domellöf, Umeå University

Iron Absorption From Iron-fortified 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 901 85
        • Department of Clinical Sciences, Pediatrics, Umeå University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iron drops
Dietary supplement: 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
Experimental: iron-fortified formula (2.3 mg iron/L)
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
Experimental: iron-fortified formula (12.4 mg iron /L)
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
iron absorption
Time Frame: 1 month after enrollment
1 month after enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

University of California, Davis
Swiss Federal Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 6, 2010

First Posted (Estimate)

October 7, 2010

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Iron absorption in infants

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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