Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation (BFe01B1)
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Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Predominantly breastfed (at 4 months) term infants
Exclusion criteria
- Not predominantly breastfed at 4 months
- Premature infants
Trial design
Primary purpose
Allocation
Interventional model
Masking
171 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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