NCT00998998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
277

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 1992

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1992

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1996

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1996

Completed
13.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
Last Updated

July 21, 2010

Status Verified

June 1, 2010

Enrollment Period

4.3 years

First QC Date

October 20, 2009

Last Update Submit

July 19, 2010

Conditions

Iron Deficiency Anemia

Keywords

iron deficiency anemiainfant behaviorinfant development

Outcome Measures

Primary Outcomes (1)

  • Infant behavior and development

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

Secondary Outcomes (1)

  • Iron-deficiency anemia

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

Study Arms (4)

1

EXPERIMENTAL

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 stimulationDietary Supplement: Iron

2

ACTIVE COMPARATOR

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: SurveillanceDietary Supplement: Iron

3

EXPERIMENTAL

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

Behavioral: Home stimulationDietary Supplement: Iron

4

ACTIVE COMPARATOR

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

Behavioral: SurveillanceDietary Supplement: Iron

Interventions

Home stimulationBEHAVIORAL

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

13
SurveillanceBEHAVIORAL

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

24
IronDIETARY_SUPPLEMENT

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.

1234

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Nutrición y Tecnología de los Alimentos (INTA)

Santiago, Chile

Location

Related Publications (1)

  • 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.

    PMID: 20855384DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyInfant Behavior

Interventions

Iron

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesChild BehaviorBehavior

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Study Officials

  • Betsy Lozoff, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

April 1, 1992

Primary Completion

July 1, 1996

Study Completion

July 1, 1996

Last Updated

July 21, 2010

Record last verified: 2010-06

Locations

CL(1)