Fomon Infant Nutrition Unit
Iowa City, Iowa, 52242, United States
NCT Number: NCT00760890
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.
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Notify Me1 month–24 month
All sexes
Interventional
Not applicable
Iowa City, Iowa, 52242, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
7.5 mg/day in the form of 0.3 ml once each day
1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
Time frame: 3 times during the intervention
Time frame: At the end of intervention
Time frame: During intervention
National Institutes of Health (NIH)
Nih
Acronym: BFe01B1
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