Cereals as a Source of Iron for Breastfed Infants

Breast Feeding and Iron: Comparison of Cereals Fortified With Different Forms of Iron

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00841061

Acronym

Bfe03B

Enrollment

111

Registered

2009-02-11

Start date

2003-07-31

Completion date

2006-05-31

Last updated

2009-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

Brief summary

The purpose of this research study is to determine whether the type of iron in infant cereals makes a differance in how well the cereal helps infants remain free of iron deficiency.

Interventions

DIETARY_SUPPLEMENTelectrolytic iron

1/4 a cup of cereal fortified with electrolytic iron per day between the ages of 112 days and 280 days of age

DIETARY_SUPPLEMENTferrous fumarate

1/4 cup of cereal fortified with ferrous fumarate to be fed per day between ages of 112 days and 280 days of age

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

28 Days to 1 Years

Healthy volunteers

Yes

Inclusion criteria

* exclusively breastfed * birth weight between 2500 and 4200g * gestational age \>36 weeks

Exclusion criteria

* supplementing formula * no iron drops

Design outcomes

Primary

Measure	Time frame
plasma ferritin	280 days

Secondary

Measure	Time frame
hemoglobin	280

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026