Iron Supplementation of Lead-exposed Infants | NCT00374790

Studies
Iron Supplementation of Lead-exposed Infants

NCT00374790

Sponsor

Cornell University

Status

Completed

Last Update Posted

May 15, 2018Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Lead Toxicity

Interventions

Ferrous sulfate

Countries

Uruguay

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

May 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Sep 8, 2006

First Submission Date that Met QC Criteria

Sep 8, 2006

First Posted Date

Sep 11, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2018

Last Update Posted Date

May 15, 2018Actual

Name	Class
Thrasher Research Fund	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Ferrous sulfate	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of blood lead concentrations > 10 mcg/dL
Mean hemoglobin concentration
Mean zinc protoporphyrin concentration

Secondary Outcomes

Measure	Description	Time Frame
Anthropometry
Oxidative stress

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

18 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katarzyna Kordas, PhD	Cornell University	Principal Investigator
Rebecca J Stoltzfus, PhD	Cornell University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic for Environmnetal Contaminants		Montevideo			Uruguay

Intervention Browse Module

MeSH Terms

ID	Term
C020748	ferrous sulfate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided