NCT00374790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

September 8, 2006

Last Update Submit

May 9, 2018

Conditions

Lead Toxicity

Keywords

Lead toxicity

Outcome Measures

Primary Outcomes (3)

  • Incidence of blood lead concentrations > 10 mcg/dL

  • Mean hemoglobin concentration

  • Mean zinc protoporphyrin concentration

Secondary Outcomes (2)

  • Anthropometry

  • Oxidative stress

Interventions

Ferrous sulfateDRUG

Eligibility Criteria

Age6 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Hemoglobin \>11.5 g/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Environmnetal Contaminants

Montevideo, Uruguay

Location

MeSH Terms

Interventions

ferrous sulfate

Study Officials

  • Katarzyna Kordas, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

  • Rebecca J Stoltzfus, PhD

    Cornell University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

October 1, 2006

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

UR(1)