Lead Toxicity Clinical Trial
Official title:
Pilot Study to Determine the Efficacy of Iron Supplementation in Preventing the Elevation of Blood Lead Concentrations in Young Children
| NCT number | NCT00374790 |
| Other study ID # | 0604015 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | October 2006 |
| Est. completion date | July 2008 |
| Verified date | May 2018 |
| Source | Cornell University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | July 2008 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Months to 18 Months |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Uruguay | Clinic for Environmnetal Contaminants | Montevideo |
| Lead Sponsor | Collaborator |
|---|---|
| Cornell University | Thrasher Research Fund |
Uruguay,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of blood lead concentrations > 10 mcg/dL | |||
| Primary | Mean hemoglobin concentration | |||
| Primary | Mean zinc protoporphyrin concentration | |||
| Secondary | Anthropometry | |||
| Secondary | Oxidative stress |