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

NCT01216709 | Completed

• 1 other identifier: Iron absorption in infants
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant; Dietary Supplements; Food, Fortified

Keywords

Infant; Dietary Supplements; Food, Fortified; Iron Absorption

Outcome Measures

Primary Outcomes (1)

• iron absorption

  1 month after enrollment

Secondary Outcomes (2)

• indicators of iron metabolism, growth, and oxidative stress

  1 month and 1.5 months after enrollment

• zinc absorption

  1 month after enrollment

Study Arms (3)

iron drops

EXPERIMENTAL

Dietary Supplement: ferrous sulfate

iron-fortified formula (2.3 mg iron/L)

EXPERIMENTAL

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

iron-fortified formula (12.4 mg iron /L)

EXPERIMENTAL

Other: iron-fortified infant formula (12.4 mg iron/L)

Interventions

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 drops

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 formula (12.4 mg iron /L)

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

iron-fortified formula (2.3 mg iron/L)

Eligibility Criteria

• Age: 6 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• iron deficiency at enrollment
• previous or current use of iron supplements

Sponsors & Collaborators

• Umeå University: lead
• Swiss Federal Institute of Technology: collaborator
• University of California, Davis: collaborator

Study Sites (1)

Department of Clinical Sciences, Pediatrics, Umeå University Hospital

Umeå, 901 85, Sweden

Location

MeSH Terms

Interventions

ferrous sulfate

Study Officials

• Magnus Domellöf, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

SE (1)