The Anemia Control Program: Early Intervention

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia

• Registration Number: NCT00998998
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Study Timeline

• Study Start: 1992-04
• Primary Completion: 1996-07
• Study Completion: 1996-07
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Status Verified: 2010-06
• Last Update Submitted: 2010-07-19
• Last Update Posted: 2010-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 277

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infant behavior and development	6, 12, and 18 months; or 12, 18, and 24 months

Secondary Outcome Measures

Name	Time	Method
Iron-deficiency anemia	6, 12, and 18 months; or 12, 18 and 24 months

Trial Locations

Locations (1)

Instituto de Nutrición y Tecnología de los Alimentos (INTA); 🇨🇱 Santiago, Chile