Completed

NCT Number: NCT00374790

Iron Supplementation of Lead-exposed Infants

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.

Completed

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Key information

Conditions

Lead Toxicity

Age range

6 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinic for Environmnetal Contaminants

Montevideo, Uruguay

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ferrous Sulfate

Drug

Primary outcomes

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

Secondary outcomes

Anthropometry
Oxidative stress

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

Thrasher Research Fund

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Sep 11, 2006
Registry last updated: May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.