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The Anemia Control Program: Early Intervention

Primary Purpose

Iron Deficiency Anemia

Status

Completed

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Home stimulation

Surveillance

Iron

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring iron deficiency anemia, infant behavior, infant development

Eligibility Criteria

6 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Instituto de Nutrición y Tecnología de los Alimentos (INTA)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Arm Description

6 or 12 month old infants with iron deficiency anemia assigned to receive home stimulation program via weekly home visits over 1 year

6 or 12 month old infants with iron deficiency anemia assigned to surveillance (weekly visits to monitor health and iron supplement) over 1 year

Nonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year

Nonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year

Outcomes

Primary Outcome Measures

Infant behavior and development

Secondary Outcome Measures

Iron-deficiency anemia

Full Information

NCT ID

NCT00998998

First Posted

October 20, 2009

Last Updated

July 19, 2010

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00998998

Brief Title

The Anemia Control Program: Early Intervention

Official Title

Iron Deficiency Anemia and Infant Behavior: Early Intervention Study II

Study Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Completed

Study Start Date

April 1992 (undefined)

Primary Completion Date

July 1996 (Actual)

Study Completion Date

July 1996 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

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

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

Keywords

iron deficiency anemia, infant behavior, infant development

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

277 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

6 or 12 month old infants with iron deficiency anemia assigned to receive home stimulation program via weekly home visits over 1 year

Arm Title

Arm Type

Active Comparator

Arm Description

6 or 12 month old infants with iron deficiency anemia assigned to surveillance (weekly visits to monitor health and iron supplement) over 1 year

Arm Title

Arm Type

Experimental

Arm Description

Nonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year

Arm Title

Arm Type

Active Comparator

Arm Description

Nonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year

Intervention Type

Behavioral

Intervention Name(s)

Home stimulation

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Surveillance

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron

Intervention Description

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 Outcome Measure Information:

Title

Infant behavior and development

Time Frame

6, 12, and 18 months; or 12, 18, and 24 months

Secondary Outcome Measure Information:

Title

Iron-deficiency anemia

Time Frame

6, 12, and 18 months; or 12, 18 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Betsy Lozoff, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Instituto de Nutrición y Tecnología de los Alimentos (INTA)

City

Santiago

Country

Chile

12. IPD Sharing Statement

Citations:

PubMed Identifier

20855384

Citation

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. doi: 10.1542/peds.2009-3535. Epub 2010 Sep 20.

Results Reference

derived

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The Anemia Control Program: Early Intervention

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