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

NCT01216709 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2020-03-26

No results posted yet for this study

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

Interventions

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

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

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

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    collaborator OTHER

  • University of California, Davis

    collaborator OTHER

  • Umeå University

    lead OTHER

Principal Investigators

  • Magnus Domellöf, MD, PhD · Umeå University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01216709 on ClinicalTrials.gov