Iron Deficiency
Conditions
Keywords
Iron, breastfed infant
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.
Interventions
DIETARY_SUPPLEMENTFer-In-Sol (ferrous sulfate)
7.5 mg/day in the form of 0.3 ml once each day
DIETARY_SUPPLEMENTIron fortified cereal
1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
Sponsors
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
* Predominantly breastfed (at 4 months) term infants
Exclusion criteria
* Not predominantly breastfed at 4 months * Premature infants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Iron status | 3 times during the intervention |
Secondary
| Measure | Time frame |
|---|---|
| Growth | At the end of intervention |
| Tolerance (gastrointestinal) | During intervention |
Countries
United States
Outcome results
None listed