This one Popped up on my Medscape newsletter - another good example of
thing more is more when it comes to formula, and the ongoing danger of
this "mass uncontrolled trial in infant feeding" -- Dawn Kersula in
Vermont
Iron-Fortified vs Low-Iron Infant Formula
Developmental Outcome at 10 Years
Betsy Lozoff, MD; Marcela Castillo, PhD; Katy M. Clark, MA; Julia B. Smith, EdD
Arch Pediatr Adolesc Med. 2012;166(3):208-215.
doi:10.1001/archpediatrics.2011.197
Objective To assess long-term developmental outcome in children who
received iron-fortified or low-iron formula.
Design Follow-up at 10 years of a randomized controlled trial
(1991-1994) of 2 levels of formula iron. Examiners were masked to
group assignment.
Setting Urban areas around Santiago, Chile.
Participants The original study enrolled healthy, full-term infants
in community clinics; 835 completed the trial. At 10 years, 473 were
assessed (56.6%).
Intervention Iron-fortified (mean, 12.7 mg/L) or low-iron (mean, 2.3
mg/L) formula from 6 to 12 months.
Main Outcome Measures We measured IQ, spatial memory, arithmetic
achievement, visual-motor integration, visual perception, and motor
functioning. We used covaried regression to compare iron-fortified and
low-iron groups and considered hemoglobin level before randomization
and sensitivity analyses to identify 6-month hemoglobin levels at
which groups diverged in outcome.
Results Compared with the low-iron group, the iron-fortified group
scored lower on every 10-year outcome (significant for spatial memory
and visual-motor integration; suggestive for IQ, arithmetic
achievement, visual perception, and motor coordination; 1.4-4.6 points
lower; effect sizes, 0.13-0.21). Children with high 6-month hemoglobin
levels (>12.8 g/dL [to convert to grams per liter, multiply by 10])
showed poorer outcome on these measures if they received
iron-fortified formula (10.7-19.3 points lower; large effect sizes,
0.85-1.36); those with low hemoglobin levels (<10.5 g/dL) showed
better outcome (2.6-4.5 points higher; small but significant effects,
0.22-0.36). High hemoglobin levels represented 5.5% of the sample (n =
26) and low hemoglobin levels represented 18.4% (n = 87).
Conclusion Long-term development may be adversely affected in infants
with high hemoglobin levels who receive 12.7 mg/L of iron-fortified
formula. Optimal amounts of iron in infant formula warrant further
study.
Trial Registration clinicaltrials.gov Identifier: NCT01166451
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