Prevention of Iron Deficiency in Breastfed Infants

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01444261

First Posted: September 30, 2011

Last Update Posted: March 31, 2017

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Collaborator:

University of Iowa

Information provided by (Responsible Party):

Ekhard Ziegler, University of Iowa

Purpose

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

Condition	Intervention	Phase
Iron Deficiency Anemia	Dietary Supplement: Fer-in-Sol Other: control	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention
Official Title:	Prevention of Iron Deficiency in Breastfed Infants

Resource links provided by NLM:

MedlinePlus related topics: Anemia Breastfeeding Iron

Drug Information available for: Iron, elemental Ferrous sulfate heptahydrate

U.S. FDA Resources

Further study details as provided by Ekhard Ziegler, University of Iowa:

Primary Outcome Measures:

Iron deficiency anemia will be prevented in all infants before 5.5 mo of age [ Time Frame: 5.5 mo ]
Iron deficiency anemia will be defined as plasma ferritin less than 10 ug/L and hemoglobin less than 105 g/L. The expected outcome is there will be no infants with iron deficiency anemia before 5.5 mo of age.

Secondary Outcome Measures:

Determine the number of infants with iron deficiency between 5.5 and 9 mo of age [ Time Frame: 9 mo ]
Iron deficiency will be determined as plasma ferritin less than 10 ug/L. We will determine the number of infants with iron deficiency between 5.5 and 9 mo of age


Enrollment:	219
Study Start Date:	December 2010
Study Completion Date:	April 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intervention Fer-in-Sol drops and iron-fortified cereal	Dietary Supplement: 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
Control No intervention	Other: control No dietary supplements

Detailed Description:

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 9 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01444261

Locations


United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

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

University of Iowa

Investigators


Principal Investigator:	Ekhard Ziegler, MD	University of Iowa

More Information


Responsible Party:	Ekhard Ziegler, Professor, University of Iowa
ClinicalTrials.gov Identifier:	NCT01444261 History of Changes
Other Study ID Numbers:	BFe10D
First Submitted:	September 28, 2011
First Posted:	September 30, 2011
Last Update Posted:	March 31, 2017
Last Verified:	March 2017

Keywords provided by Ekhard Ziegler, University of Iowa:


iron deficiency anemia

Additional relevant MeSH terms:


Anemia, Iron-Deficiency Anemia, Hypochromic Anemia Hematologic Diseases Iron Metabolism Disorders Metabolic Diseases	Iron Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs

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