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Iron Supplementation of Lead-exposed Infants

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ClinicalTrials.gov Identifier: NCT00374790
Recruitment Status : Completed
First Posted : September 11, 2006
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Cornell University

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.

Condition or disease Intervention/treatment Phase
Lead Toxicity Drug: Ferrous sulfate Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : October 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron




Primary Outcome Measures :
  1. Incidence of blood lead concentrations > 10 mcg/dL
  2. Mean hemoglobin concentration
  3. Mean zinc protoporphyrin concentration

Secondary Outcome Measures :
  1. Anthropometry
  2. Oxidative stress


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 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

Exclusion criteria:

  • Hemoglobin >11.5 g/dL

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


Locations
Uruguay
Clinic for Environmnetal Contaminants
Montevideo, Uruguay
Sponsors and Collaborators
Cornell University
Thrasher Research Fund
Investigators
Principal Investigator: Katarzyna Kordas, PhD Cornell University
Study Chair: Rebecca J Stoltzfus, PhD Cornell University

Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT00374790     History of Changes
Other Study ID Numbers: 0604015
First Posted: September 11, 2006    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Cornell University:
Lead toxicity