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The Anemia Control Program: Early Intervention

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00998998
First received: October 20, 2009
Last updated: July 19, 2010
Last verified: June 2010
History of Changes

October 20, 2009
July 19, 2010
April 1992
July 1996   (final data collection date for primary outcome measure)
Infant behavior and development [ Time Frame: 6, 12, and 18 months; or 12, 18, and 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00998998 on ClinicalTrials.gov Archive Site
Iron-deficiency anemia [ Time Frame: 6, 12, and 18 months; or 12, 18 and 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Anemia Control Program: Early Intervention
Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Iron Deficiency Anemia
  • Behavioral: Home stimulation
    Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
  • Behavioral: 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.
  • Experimental: 1
    6 or 12 month old infants with iron deficiency anemia assigned to receive home stimulation program via weekly home visits over 1 year
    Interventions:
    • Behavioral: Home stimulation
    • Dietary Supplement: Iron
  • Active Comparator: 2
    6 or 12 month old infants with iron deficiency anemia assigned to surveillance (weekly visits to monitor health and iron supplement) over 1 year
    Interventions:
    • Behavioral: Surveillance
    • Dietary Supplement: Iron
  • Experimental: 3
    Nonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year
    Interventions:
    • Behavioral: Home stimulation
    • Dietary Supplement: Iron
  • Active Comparator: 4
    Nonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year
    Interventions:
    • Behavioral: Surveillance
    • Dietary Supplement: Iron
Lozoff B, Smith JB, Clark KM, Perales CG, Rivera F, Castillo M. Home intervention improves cognitive and social-emotional scores in iron-deficient anemic infants. Pediatrics. 2010 Oct;126(4):e884-94. Epub 2010 Sep 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
277
July 1996
July 1996   (final data collection date for primary outcome measure)

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
Both
6 Months to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00998998
R01 HD14122
Not Provided
Betsy Lozoff, MD, Professor of Pediatrics and Communicable Diseases and Research Professor, Center for Human Growth and Development, University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Betsy Lozoff, MD University of Michigan
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP