Cognitive Development, Iron Deficiency Anemia, Motor Development
Conditions
Keywords
iron deficiency anemia, cognitive development, motor development
Brief summary
The purpose of this clinical trial was to determine if high-iron or low-iron formula, containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron status in infancy and on development longitudinally.
Detailed description
For a detailed description of the clinical trial setting and procedures in infancy, please refer to the following: Walter T, Pino P, Pizarro F and Lozoff B. Prevention of iron-deficiency anemia: Comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pedr 1998:132:635-40.
Interventions
DIETARY_SUPPLEMENTLow-iron formula
Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age. Low-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)
DIETARY_SUPPLEMENTHigh-iron formula
Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age. High-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Months
Healthy volunteers
No
Inclusion criteria
* Birth weight \>= 3.0 kg * single birth * no major congenital anomalies * no major birth or neonatal complications * no emergency c-section * no jaundice requiring phototherapy * no hospitalization for more than 5 days * no chronic illness * no iron therapy * already started to received some bottle feedings by 6 months of age
Exclusion criteria
* residence outside identified neighborhoods * another infant \<12 months in household * infant in daycare * unstable, illiterate, or psychotic caregiver
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Iron deficiency anemia | 12 and 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Longitudinal child behavior and development | 10 years |
Countries
Chile
Outcome results
None listed