Iron Supplementation of Lead-exposed Infants

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374790

Enrollment

Registered

2006-09-11

Start date

2006-10-31

Completion date

2008-07-31

Last updated

2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lead Toxicity

Keywords

Lead toxicity

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.

Interventions

DRUGFerrous sulfate

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Months to 18 Months

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

Design outcomes

Primary

Measure	Time frame
Incidence of blood lead concentrations > 10 mcg/dL	—
Mean hemoglobin concentration	—
Mean zinc protoporphyrin concentration	—

Secondary

Measure	Time frame
Anthropometry	—
Oxidative stress	—

Countries

Uruguay

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026