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Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children

NCT01573013 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2014-05-12

No results posted yet for this study

Summary

In a cross-sectional study allotted by the ethical committee of the ETH Zurich, we are investigating the extent of anemia, iron deficiency and lead intoxication in young children. For this purpose an assessment of body lead burden and iron status was conducted in a cohort of individuals residing in areas of presumed high lead exposure. Associations between lead burden and iron status will be investigated in the near future (current status of the study).

In a follow-on intervention study, the effect of iron fortification with and without NaEDTA on blood lead levels in lead-exposed children will be evaluated; and the relative impact of these two strategies on child growth, motor and cognitive test performance will be compared.

This study will investigate the potential use of iron fortification to not only combat anemia but also reduce body lead burden in lead-exposed populations; it specifically investigates whether iron fortification with NaFeEDTA could have additional beneficial effects to iron alone.

Conditions

Interventions

DIETARY_SUPPLEMENT

iron fortified biscuits

10 mg of iron per day for 8 months, either in the form of NaFeEDTA

DIETARY_SUPPLEMENT

iron fortified biscuits

10 mg of iron per day for 8 months, in the form of FeSo4

DIETARY_SUPPLEMENT

iron fortified biscuits

EDTA fortified biscuit on a daily basis for 8 months

DIETARY_SUPPLEMENT

iron fortified biscuits

control biscuit on a daily basis for 8 months

Sponsors & Collaborators

  • Swiss Federal Institute of Technology

    lead OTHER

Principal Investigators

  • Michael B Zimmermann, Prof. Dr. med · Swiss Federal Institute of Technology (ETH)

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
3 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01573013 on ClinicalTrials.gov