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Iron Supplementation of Lead-Exposed Infants

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by Cornell University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00374790
First Posted: September 11, 2006
Last Update Posted: September 11, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Thrasher Research Fund
Information provided by:
Cornell University
  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
Intervention Model: Single Group Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00374790     History of Changes
Other Study ID Numbers: 0604015
First Submitted: September 8, 2006
First Posted: September 11, 2006
Last Update Posted: September 11, 2006
Last Verified: May 2006

Keywords provided by Cornell University:
Lead toxicity