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Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation

NCT ID: NCT00760890

Last Updated: 2008-09-26

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

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2005-10-31

Brief Summary

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Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested the hypothesis that regular provision of a source of iron beginning at 4 months of age improves iron status and could prevent iron deficiency. This was a prospective randomized trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed (\<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to one of two interventions or to control. The interventions consisted in the daily administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal Group). The control group received complementary foods chosen by he parents but no source of iron provided by the investigators. The interventions took place from 4 to 9 months. All infants were subsequently followed to 2 years of age.

Detailed Description

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Conditions

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Iron Deficiency

Keywords

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Iron, breastfed infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Medicinal Iron

Group Type EXPERIMENTAL

Fer-In-Sol (ferrous sulfate)

Intervention Type DIETARY_SUPPLEMENT

7.5 mg/day in the form of 0.3 ml once each day

B

Iron fortified wet pack cereal

Group Type EXPERIMENTAL

Iron fortified cereal

Intervention Type DIETARY_SUPPLEMENT

1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.

C

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fer-In-Sol (ferrous sulfate)

7.5 mg/day in the form of 0.3 ml once each day

Intervention Type DIETARY_SUPPLEMENT

Iron fortified cereal

1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Predominantly breastfed (at 4 months) term infants

Exclusion Criteria

* Not predominantly breastfed at 4 months
* Premature infants
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

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, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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Fomon Infant Nutrition Unit

Iowa City, Iowa, United States

Site Status

Countries

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United States

References

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Ziegler EE, Nelson SE, Jeter JM. Iron status of breastfed infants is improved equally by medicinal iron and iron-fortified cereal. Am J Clin Nutr. 2009 Jul;90(1):76-87. doi: 10.3945/ajcn.2008.27350. Epub 2009 May 20.

Reference Type DERIVED
PMID: 19458014 (View on PubMed)

Other Identifiers

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R01HD040315

Identifier Type: NIH

Identifier Source: org_study_id

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