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Clinical Trials/NCT01166451
NCT01166451
Completed
Not Applicable

Iron Deficiency Anemia and Infant Behavior: Preventive Trial

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)1 site in 1 country835 target enrollmentSeptember 1991
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ConditionsIron Deficiency AnemiaCognitive DevelopmentMotor Development

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Iron Deficiency Anemia
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Enrollment
835
Locations
1
Primary Endpoint
Iron deficiency anemia
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this clinical trial was to determine if high-iron or low-iron formula, containing an average of 12.7 mg/L or 2.3 mg/L respectively, had differing effects on iron status in infancy and on development longitudinally.

Detailed Description

For a detailed description of the clinical trial setting and procedures in infancy, please refer to the following: Walter T, Pino P, Pizarro F and Lozoff B. Prevention of iron-deficiency anemia: Comparison of high- and low-iron formulas in term healthy infants after six months of life. J Pedr 1998:132:635-40.

Registry
clinicaltrials.gov
Start Date
September 1991
End Date
March 2004
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • •Birth weight \>= 3.0 kg
  • •single birth
  • •no major congenital anomalies
  • •no major birth or neonatal complications
  • •no emergency c-section
  • •no jaundice requiring phototherapy
  • •no hospitalization for more than 5 days
  • •no chronic illness
  • •no iron therapy
  • •already started to received some bottle feedings by 6 months of age

Exclusion Criteria

  • •residence outside identified neighborhoods
  • •another infant \<12 months in household
  • •infant in daycare
  • •unstable, illiterate, or psychotic caregiver

Outcomes

Primary Outcomes

Iron deficiency anemia

Time Frame: 12 and 18 months

Secondary Outcomes

  • Longitudinal child behavior and development(10 years)

Study Sites (1)

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