The Anemia Control Program: Early Intervention

Iron Deficiency Anemia Clinical Trial

Official title:

Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00998998
• Other study ID #: R01HD014122
• Status: Completed
• Phase: N/A
• First received: October 20, 2009
• Last updated: July 19, 2010
• Start date: April 1992
• Est. completion date: July 1996

Study information

• Verified date: June 2010
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: July 1996
• Est. primary completion date: July 1996
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Behavioral:
• Home stimulation
Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
• Surveillance
Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.

Dietary Supplement:
• Iron
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.

Locations

Country	Name	City	State
Chile	Instituto de Nutrición y Tecnología de los Alimentos (INTA)	Santiago

Sponsors (1)

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

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant behavior and development		6, 12, and 18 months; or 12, 18, and 24 months	No
Secondary	Iron-deficiency anemia		6, 12, and 18 months; or 12, 18 and 24 months	No