Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
277 participants
INTERVENTIONAL
1992-04-30
1996-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
6 or 12 month old infants with iron deficiency anemia assigned to receive home stimulation program via weekly home visits over 1 year
Home stimulation
Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
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.
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
Surveillance
Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.
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.
3
Nonanemic infants identified at 6 or 12 months assigned to receive home stimulation program via weekly home visits over 1 year
Home stimulation
Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
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.
4
Nonanemic infants identified at 6 and 12 months assigned to surveillance (weekly visits to monitor health) over 1 year
Surveillance
Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.
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.
Interventions
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Home stimulation
Weekly visit of one hour to the home over the course of one year to foster the mother-child relationship.
Surveillance
Weekly visits to the home over the course of one year to record iron intake, feeding, and health information.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Months
12 Months
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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University of Michigan
Principal Investigators
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Betsy Lozoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Instituto de Nutrición y Tecnología de los Alimentos (INTA)
Santiago, , Chile
Countries
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References
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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.
Other Identifiers
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