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Clinical Trials/NCT00374790
NCT00374790CompletedPhase 2

Pilot Study to Determine the Efficacy of Iron Supplementation in Preventing the Elevation of Blood Lead Concentrations in Young Children

Cornell University1 site in 1 country50 target enrollmentStarted: October 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Mean zinc protoporphyrin concentration
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to compare the efficacy of iron (12.5 mg as ferrous sulfate) and placebo given for 6 months in preventing the elevation of blood lead concentration in children 6-9 months of age.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
6 Months to 18 Months (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Infants included if gestational age >36 weeks, birth weight > 2500g, no chronic illness, blood lead concentration <10 mcg/dL, hemoglobin >9 g/dL, zinc protoporphyrin >90 mmol/mol heme
  • •Mothers included if 18 years or older

Exclusion Criteria

  • •Hemoglobin >11.5 g/dL

Outcomes

Primary Outcomes

Mean zinc protoporphyrin concentration

Incidence of blood lead concentrations > 10 mcg/dL

Mean hemoglobin concentration

Secondary Outcomes

  • Anthropometry
  • Oxidative stress

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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