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

Sponsor

Umeå University (Other)

Overall Status

Completed

CT.gov ID

NCT01216709

Collaborator

Swiss Federal Institute of Technology (Other), University of California, Davis (Other)

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

Study Design

Study Type:

Interventional

Actual 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)

Actual Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

iron absorption [1 month after enrollment]

Secondary Outcome Measures

indicators of iron metabolism, growth, and oxidative stress [1 month and 1.5 months after enrollment]
zinc absorption [1 month after enrollment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 7 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Sciences, Pediatrics, Umeå University Hospital	Umeå		Sweden	901 85

Sponsors and Collaborators

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

Investigators

Principal Investigator: Magnus Domellöf, MD, PhD, Umeå University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Magnus Domellöf, MD, PhD, Umeå University

ClinicalTrials.gov Identifier:

NCT01216709

Other Study ID Numbers:

Iron absorption in infants

First Posted:

Oct 7, 2010

Last Update Posted:

Mar 26, 2020

Last Verified:

Mar 1, 2020

Keywords provided by Magnus Domellöf, MD, PhD, Umeå University

Additional relevant MeSH terms:

Iron

Study Results

No Results Posted as of Mar 26, 2020