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Iron Supplementation of Lead-Exposed Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Cornell University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by:
Cornell University
ClinicalTrials.gov Identifier:
NCT00374790
First received: September 8, 2006
Last updated: NA
Last verified: May 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Lead Toxicity
 Drug: Ferrous sulfate
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Pilot Study to Determine the Efficacy of Iron Supplementation in Preventing the Elevation of Blood Lead Concentrations in Young Children

Resource links provided by NLM:

MedlinePlus related topics: Iron
U.S. FDA Resources

Further study details as provided by Cornell University:

Primary Outcome Measures:
  • Incidence of blood lead concentrations > 10 mcg/dL
  • Mean hemoglobin concentration
  • Mean zinc protoporphyrin concentration

Secondary Outcome Measures:
  • Anthropometry
  • Oxidative stress

Estimated Enrollment: 50
Study Start Date: October 2006
  Eligibility

Ages Eligible for Study:   6 Months to 9 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374790

Contacts
Contact: Katarzyna Kordas, PhD 607-273-4449 kk326@cornell.edu

Locations
Uruguay
Clinic for Environmnetal Contaminants Not yet recruiting
Montevideo, Uruguay
Principal Investigator: Elena Queirolo, MD            
Sponsors and Collaborators
Cornell University
Thrasher Research Fund
Investigators
Principal Investigator: Katarzyna Kordas, PhD Cornell University
Study Chair: Rebecca J Stoltzfus, PhD Cornell University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374790     History of Changes
Other Study ID Numbers: 0604015
Study First Received: September 8, 2006
Last Updated: September 8, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Cornell University:
Lead toxicity

ClinicalTrials.gov processed this record on June 18, 2013