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

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ClinicalTrials.gov Identifier: NCT01216709
Recruitment Status : Unknown
Verified June 2012 by Magnus Domellöf, Umeå University.
Recruitment status was:  Recruiting
First Posted : October 7, 2010
Last Update Posted : June 14, 2012
Sponsor:
Collaborators:
Swiss Federal Institute of Technology
University of California, Davis
Information provided by (Responsible Party):
Magnus Domellöf, Umeå University

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.

Condition or disease Intervention/treatment Phase
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) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Iron Absorption From Iron-fortified Infant Formula and Iron Drops in Infants (MJAU-studien)
Study Start Date : October 2010
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. iron absorption [ Time Frame: 1 month after enrollment ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 7 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Magnus Domellöf, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01216709     History of Changes
Other Study ID Numbers: Iron absorption in infants
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

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

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