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CompletedNCT00374790Updated May 15, 2018

Iron Supplementation of Lead-exposed Infants

A Phase 2 interventional study of Ferrous sulfate in Lead Toxicity, sponsored by Cornell University. Completed at 1 site in Uruguay. Open to participants aged 6 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by Cornell University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
6 Months to 18 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Lead Toxicity

Keywords

  • Lead toxicity
03

In context

Lead sponsor

Cornell University is the lead sponsor of 103 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • Hemoglobin >11.5 g/dL
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
50 participants (estimated)

Interventions

06

What researchers measure

Primary outcomes

  1. Incidence of blood lead concentrations > 10 mcg/dL

  2. Mean hemoglobin concentration

  3. Mean zinc protoporphyrin concentration

Secondary outcomes

  1. Anthropometry

  2. Oxidative stress

07

Study locations

1 site
  • Clinic for Environmnetal Contaminants
    Montevideo, Uruguay
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2006, a primary completion of May 2008 and a completion of Jul 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2006
First posted
Sep 11, 2006
Start
Oct 2006
Primary completionActual
May 2008
CompletionActual
Jul 2008
Last update
May 15, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00374790
Lead sponsor
Cornell University
Collaborators
Thrasher Research Fund
Responsible party
Sponsor
First posted
Sep 11, 2006
Start date
Oct 2006
Primary completion
May 2008
Completion
Jul 2008
Last update
May 15, 2018

Study contacts

Katarzyna Kordas, PhD
principal investigator · Cornell University
Rebecca J Stoltzfus, PhD
study chair · Cornell University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ferrous sulfate

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