Clinical trial NCT01166451: The Anemia Control Program: High or Low Iron Supplementation
Official title: Iron Deficiency Anemia and Infant Behavior: Preventive Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Cognitive Development
Motor Development
Keywords: iron deficiency anemia
cognitive development
motor development
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2010-07-21
Enrollment: 835
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Iron deficiency anemia
timeFrame: 12 and 18 months
Secondary outcomes:
measure: Longitudinal child behavior and development
timeFrame: 10 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto de Nutriticion y Tecnologia de los Alimentos
Study officials:
affiliation: University of Michigan
name: Betsy Lozoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walter T, Pino P, Pizarro F, Lozoff B. Prevention of iron-deficiency anemia: comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pediatr. 1998 Apr;132(4):635-40. doi: 10.1016/s0022-3476(98)70352-x.
citation: East PL, Reid B, Blanco E, Burrows R, Lozoff B, Gahagan S. Iron supplementation given to nonanemic infants: neurocognitive functioning at 16 years. Nutr Neurosci. 2023 Jan;26(1):40-49. doi: 10.1080/1028415X.2021.2013399. Epub 2021 Dec 19.
citation: East P, Doom J, Blanco E, Burrows R, Lozoff B, Gahagan S. Young adult outcomes associated with lower cognitive functioning in childhood related to iron-fortified formula in infancy. Nutr Neurosci. 2022 Apr;25(4):709-718. doi: 10.1080/1028415X.2020.1804099. Epub 2020 Aug 11.
citation: Gahagan S, Delker E, Blanco E, Burrows R, Lozoff B. Randomized Controlled Trial of Iron-Fortified versus Low-Iron Infant Formula: Developmental Outcomes at 16 Years. J Pediatr. 2019 Sep;212:124-130.e1. doi: 10.1016/j.jpeds.2019.05.030. Epub 2019 Jun 26.
citation: Lozoff B, Castillo M, Clark KM, Smith JB. Iron-fortified vs low-iron infant formula: developmental outcome at 10 years. Arch Pediatr Adolesc Med. 2012 Mar;166(3):208-15. doi: 10.1001/archpediatrics.2011.197. Epub 2011 Nov 7.