The Anemia Control Program: Early Intervention

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Iron Deficiency Anemia

Treatments: Dietary Supplement: Iron; Behavioral: Surveillance; Behavioral: Home stimulation

Study type: Interventional

Funder types: NIH

Identifiers

NCT00998998

R01HD014122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 277 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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277 participants in 4 patient groups

1

Experimental group

Description:

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

Treatment:

Dietary Supplement: Iron

Behavioral: Home stimulation

2

Active Comparator group

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

Treatment:

Dietary Supplement: Iron

Behavioral: Surveillance

3

Experimental group

Description:

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

Treatment:

Dietary Supplement: Iron

Behavioral: Home stimulation

4

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Iron

Behavioral: Surveillance