Skip to main content
OpenTrials
Completed

NCT Number: NCT00998998

The Anemia Control Program: Early Intervention

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Nutrición y Tecnología de los Alimentos (INTA)

Santiago, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home stimulation

Behavioral

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

Surveillance

Behavioral

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

Iron

Dietary Supplement

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.

Primary outcomes

  1. Infant behavior and development

    Time frame: 6, 12, and 18 months; or 12, 18, and 24 months

Secondary outcomes

  1. Iron-deficiency anemia

    Time frame: 6, 12, and 18 months; or 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

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

Nih

Registry information

Official study title

Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

Important dates

Study start
1992
Primary completion
1996
Study completion
1996
First posted
Oct 21, 2009
Registry last updated
Jul 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.