Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation
BFe01B1
1 other identifier
interventional
171
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2001
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 25, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedSeptember 26, 2008
September 1, 2008
4 years
September 25, 2008
September 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Iron status
3 times during the intervention
Secondary Outcomes (2)
Growth
At the end of intervention
Tolerance (gastrointestinal)
During intervention
Study Arms (3)
A
EXPERIMENTALMedicinal Iron
B
EXPERIMENTALIron fortified wet pack cereal
C
NO INTERVENTIONControl
Interventions
1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
Eligibility Criteria
You may qualify if:
- Predominantly breastfed (at 4 months) term infants
You may not qualify if:
- Not predominantly breastfed at 4 months
- Premature infants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fomon Infant Nutrition Unit
Iowa City, Iowa, 52242, United States
Related Publications (1)
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.
PMID: 19458014DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ekhard E Ziegler, M.D.
University of Iowa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 25, 2008
First Posted
September 26, 2008
Study Start
June 1, 2001
Primary Completion
June 1, 2005
Study Completion
October 1, 2005
Last Updated
September 26, 2008
Record last verified: 2008-09