Anemia, Iron Deficiency
Conditions
Keywords
iron deficiency, anemia
Brief summary
With early screening and appropriate iron supplementation, iron deficiency in the first year of life can be prevented in breastfed infants.
Detailed description
Infants with low ferritin at 1 month are at high risk of iron deficiency. They will receive iron drops starting at 2 months. All other infants are at low risk of iron deficiency. All infants will receive iron-fortified cereal starting at 4 months of age.
Interventions
DIETARY_SUPPLEMENTFer-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
OTHERcontrol
No dietary supplements
Sponsors
University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Weeks to 9 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Iron deficiency anemia will be prevented in all infants before 5.5 mo of age | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the number of infants with iron deficiency between 5.5 and 9 mo of age | 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 |
Countries
United States
Outcome results
None listed