Clinical trial NCT00998998: The Anemia Control Program: Early Intervention
Official title: Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Keywords: iron deficiency anemia
infant behavior
infant development
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2009-10-21
Enrollment: 277
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA.

Detailed description: Iron-deficiency anemia (IDA) is associated with alterations in infant behavior and development that may not correct with iron therapy. The purpose of this study was to determine if a home-based intervention to foster child development improved behavior and development in infants with IDA. IDA and non-anemic infants were randomly assigned to a year of intervention or surveillance only. Infants were enrolled and began study participation at 6 or 12 months. All infants were treated with oral iron and visited weekly to record iron intake, feeding, and health (surveillance). For infants randomized to intervention, the weekly home visit included an hour-long program fostering child development by supporting the mother-infant relationship. Psychologists, unaware of iron status or intervention assignment, assessed cognitive, motor, and social-emotional development (Bayley Scales) at the beginning, midpoint, and end of the year.

Eligibility criteria: Inclusion Criteria:

* birth weight \>= 3.0kg
* singleton full-term birth
* routine vaginal delivery
* no major congenital anomalies
* no major perinatal complications
* no photo therapy
* no hospitalization for longer than 5 days
* no chronic illness
* no iron therapy
* from 1991-94, infants on \>= 250 ml/day cow milk or formula
* from 1994-96, infants could be on \< 250 ml/day cow milk or formula
* infants identified as anemic at 6 or 12 months and randomly selected nonanemic infants at 6 and 12 months

Exclusion Criteria:

* residence outside 4 contiguous working-class communities on outskirts of Santiago, Chile
* another infant \<12 months in household
* infant in child care
* illiterate or psychotic caregiver or no stable caregiver available to accompany the child for appointments.
* until mid-1994, "exclusive" breastfeeding, defined as \>250 mL/d cow milk or formula

Primary outcomes:
measure: Infant behavior and development
timeFrame: 6, 12, and 18 months; or 12, 18, and 24 months
Secondary outcomes:
measure: Iron-deficiency anemia
timeFrame: 6, 12, and 18 months; or 12, 18 and 24 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Instituto de Nutrición y Tecnología de los Alimentos (INTA)
Study officials:
affiliation: University of Michigan
name: Betsy Lozoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lozoff B, Smith JB, Clark KM, Perales CG, Rivera F, Castillo M. Home intervention improves cognitive and social-emotional scores in iron-deficient anemic infants. Pediatrics. 2010 Oct;126(4):e884-94. doi: 10.1542/peds.2009-3535. Epub 2010 Sep 20.