Iron Supplementation of Lead-exposed Infants

Cornell University

Status and phase: Completed; Phase 2

Conditions: Lead Toxicity

Treatments: Drug: Ferrous sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00374790

0604015

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 18 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind