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
  Purpose

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.


Condition Intervention
Iron Deficiency Anemia
Behavioral: Home stimulation
Behavioral: Surveillance
Dietary Supplement: Iron

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Infant behavior and development [ Time Frame: 6, 12, and 18 months; or 12, 18, and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Iron-deficiency anemia [ Time Frame: 6, 12, and 18 months; or 12, 18 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 277
Study Start Date: April 1992
Study Completion Date: July 1996
Primary Completion Date: July 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: Home stimulation
Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
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.
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
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: 3
Nonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year
Behavioral: Home stimulation
Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
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.
Active Comparator: 4
Nonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year
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.

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.

  Eligibility

Ages Eligible for Study:   6 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998998

Locations
Chile
Instituto de Nutrición y Tecnología de los Alimentos (INTA)
Santiago, Chile
Sponsors and Collaborators
Investigators
Principal Investigator: Betsy Lozoff, MD University of Michigan
  More Information

No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Betsy Lozoff, MD, Professor of Pediatrics and Communicable Diseases and Research Professor, Center for Human Growth and Development, University of Michigan
ClinicalTrials.gov Identifier: NCT00998998     History of Changes
Other Study ID Numbers: R01 HD14122
Study First Received: October 20, 2009
Last Updated: July 19, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
iron deficiency anemia
infant behavior
infant development

Additional relevant MeSH terms:
Anemia
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014