Prevention of Iron Deficiency in Breastfed Infants
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ClinicalTrials.gov Identifier: NCT01444261 |
Recruitment Status
:
Completed
First Posted
: September 30, 2011
Last Update Posted
: March 31, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Iron Deficiency Anemia | Dietary Supplement: Fer-in-Sol Other: control | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 219 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Prevention of Iron Deficiency in Breastfed Infants |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |
Arm | Intervention/treatment |
---|---|
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
|
- 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.
- 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

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

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
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Ekhard Ziegler, MD | University of Iowa |
Responsible Party: | Ekhard Ziegler, Professor, University of Iowa |
ClinicalTrials.gov Identifier: | NCT01444261 History of Changes |
Other Study ID Numbers: |
BFe10D |
First Posted: | September 30, 2011 Key Record Dates |
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 |