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The Anemia Control Program: Early Intervention

Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00998998
Enrollment
277
Registered
2009-10-21
Start date
1992-04-30
Completion date
1996-07-31
Last updated
2010-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency Anemia

Keywords

iron deficiency anemia, infant behavior, infant development

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.

Interventions

BEHAVIORALHome stimulation

Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.

BEHAVIORALSurveillance

Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.

DIETARY_SUPPLEMENTIron

Six-month-old infants treated orally for 1 y with 15 mg elemental Fe/d as ferrous sulfate. Twelve-month old infants treated orally for a minimum of 6 months with 30 mg elemental Fe/d.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Infant behavior and development6, 12, and 18 months; or 12, 18, and 24 months

Secondary

MeasureTime frame
Iron-deficiency anemia6, 12, and 18 months; or 12, 18 and 24 months

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026