Cereals as a Source of Iron for Breastfed Infants (Bfe03B)

National Institutes of Health (NIH)

Status: Completed

Conditions: Iron Deficiency

Treatments: Dietary Supplement: ferrous fumarate; Dietary Supplement: electrolytic iron

Study type: Interventional

Funder types: NIH

Identifiers

NCT00841061

HD40315-01

B530500

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 28 days to 1 year old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• supplementing formula
• no iron drops

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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111 participants in 2 patient groups

Cereal L

Active Comparator group

Description:

Rice cereal with electrolytic iron

Treatment:

Dietary Supplement: electrolytic iron

Cereal M

Active Comparator group

Description:

Rice cereal with ferrous fumarate

Treatment:

Dietary Supplement: ferrous fumarate