Prevention of Iron Deficiency in Breastfed Infants

NCT ID: NCT01444261

Last Updated: 2017-03-31

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

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-04-30

Brief Summary

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With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.

Detailed Description

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Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.

Conditions

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Iron Deficiency Anemia

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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Intervention

Fer-in-Sol drops and iron-fortified cereal

Group Type ACTIVE_COMPARATOR

Fer-in-Sol

Intervention Type DIETARY_SUPPLEMENT

Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal

Control

No intervention

Group Type OTHER

control

Intervention Type OTHER

No dietary supplements

Interventions

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Fer-in-Sol

Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal

Intervention Type DIETARY_SUPPLEMENT

control

No dietary supplements

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Term infants
* gestational age 37-42 weeks
* birth weight \> 2500 g
* exclusively breastfed at 28 d of age
* intend to breast feed until 9 mo of age

Exclusion Criteria

* supplemental formula before 4 mo of age
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

9 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Iowa

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role lead

Responsible Party

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Ekhard Ziegler

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ekhard 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

Other Identifiers

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BFe10D

Identifier Type: -

Identifier Source: org_study_id

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