Status:
COMPLETED
The Anemia Control Program: Early Intervention
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
6-12 years
Phase:
NA
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 interv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1996
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT00998998
Start Date
April 1 1992
End Date
July 1 1996
Last Update
July 21 2010
Active Locations (1)
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1
Instituto de Nutrición y Tecnología de los Alimentos (INTA)
Santiago, Chile