Cereals as a Source of Iron for Breastfed Infants

NCT ID: NCT00841061

Last Updated: 2009-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cereal L

Rice cereal with electrolytic iron

Group Type ACTIVE_COMPARATOR

electrolytic iron

Intervention Type DIETARY_SUPPLEMENT

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

Cereal M

Rice cereal with ferrous fumarate

Group Type ACTIVE_COMPARATOR

ferrous fumarate

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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electrolytic iron

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

Intervention Type DIETARY_SUPPLEMENT

ferrous 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* supplementing formula
* no iron drops
Minimum Eligible Age

28 Days

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role lead

Responsible Party

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University of Iowa

Principal Investigators

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Ekhard E Ziegler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Ziegler EE, Fomon SJ, Nelson SE, Jeter JM, Theuer RC. Dry cereals fortified with electrolytic iron or ferrous fumarate are equally effective in breast-fed infants. J Nutr. 2011 Feb;141(2):243-8. doi: 10.3945/jn.110.127266. Epub 2010 Dec 22.

Reference Type DERIVED
PMID: 21178077 (View on PubMed)

Other Identifiers

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HD40315-01

Identifier Type: -

Identifier Source: secondary_id

B530500

Identifier Type: -

Identifier Source: org_study_id

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