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

This study is currently recruiting participants.
Verified June 2012 by Umeå University
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
University of California, Davis
Information provided by (Responsible Party):
Magnus Domellöf, Umeå University
ClinicalTrials.gov Identifier:
NCT01216709
First received: October 6, 2010
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Infant
Dietary Supplements
Food, Fortified
 Dietary Supplement: ferrous sulfate
Other: iron-fortified infant formula (12.4 mg iron/L)
Other: iron-fortified infant formula (2.3 mg iron/L)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • iron absorption [ Time Frame: 1 month after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • indicators of iron metabolism, growth, and oxidative stress [ Time Frame: 1 month and 1.5 months after enrollment ] [ Designated as safety issue: No ]
  • zinc absorption [ Time Frame: 1 month after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: October 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01216709

Locations
Sweden
Department of Clinical Sciences, Pediatrics, Umeå University Hospital Recruiting
Umeå, Sweden, 901 85
Contact: Magnus Domellöf, MD, PhD     0046 90 7852128     magnus.domellof@pediatri.umu.se    
Contact: Ewa A Szymlek-Gay, PhD     0046 90 7852118     ewa.szymlek-gay@pediatri.umu.se    
Principal Investigator: Magnus Domellöf, MD, PhD            
Sponsors and Collaborators
Umeå University
Swiss Federal Institute of Technology
University of California, Davis
Investigators
Principal Investigator: Magnus Domellöf, MD, PhD Umeå University
  More Information

No publications provided

Responsible Party: Magnus Domellöf, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01216709     History of Changes
Other Study ID Numbers: Iron absorption in infants
Study First Received: October 6, 2010
Last Updated: June 13, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Infant
Dietary Supplements
Food, Fortified
Iron Absorption

Additional relevant MeSH terms:
Iron
Trace Elements
Micronutrients
 Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013