Iron Supplementation of Lead-exposed Infants

Phase 2

Completed

• Conditions: Lead Toxicity

• Registration Number: NCT00374790
• Lead Sponsor: Cornell University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-08
• Study First Submitted QC: 2006-09-08
• Study First Posted: 2006-09-11
• Study Start: 2006-10
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mean zinc protoporphyrin concentration
Incidence of blood lead concentrations > 10 mcg/dL
Mean hemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
Anthropometry
Oxidative stress

Trial Locations

Locations (1)

Clinic for Environmnetal Contaminants; 🇺🇾 Montevideo, Uruguay