Iron Supplementation of Lead-exposed Infants

Cornell University50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Lead Toxicity

Interventions

Ferrous sulfateDRUG

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Clinic for Environmnetal Contaminants

Montevideo, Uruguay

Outcomes

Primary Outcomes

Incidence of blood lead concentrations > 10 mcg/dL

Mean hemoglobin concentration

Mean zinc protoporphyrin concentration

Secondary Outcomes

Anthropometry

Oxidative stress

Data from ClinicalTrials.gov

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