NCT01573013

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
457

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

9 months

First QC Date

November 8, 2011

Last Update Submit

May 9, 2014

Conditions

Iron DeficiencyLead Poisoning

Keywords

iron deficiencyLead poisoningcognitive developmentmotor activity

Outcome Measures

Primary Outcomes (1)

  • body lead burden

    changes in blood lead levels over time of the intervention

    8 months

Secondary Outcomes (2)

  • Iron status

    8 months

  • cognitive development

    8 months

Study Arms (4)

NaFeEDTA treatment, biscuit

ACTIVE COMPARATOR

Group receives 10 mg of Fe in form of NaFeEDTA per day. wheat flour based biscuit

Dietary Supplement: iron fortified biscuits

EDTA treatment, biscuit

ACTIVE COMPARATOR

Group receives Na2EDTA enriched biscuit

Dietary Supplement: iron fortified biscuits

FeSO4 treatment, biscuit

ACTIVE COMPARATOR

Group receives 10 mg of iron as FeSo4 per day for 8 months

Dietary Supplement: iron fortified biscuits

control treatment, biscuit

PLACEBO COMPARATOR

group receives a biscuit without additional iron

Dietary Supplement: iron fortified biscuits

Interventions

iron fortified biscuitsDIETARY_SUPPLEMENT

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

NaFeEDTA treatment, biscuit

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • school and preschool children living in a lead-exposed environment with a high prevalence of iron deficiency

You may not qualify if:

  • chronic or severe illnesses
  • history of bleeding disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Federal Institute of Technology (ETH)

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (1)

  • Bouhouch RR, El-Fadeli S, Andersson M, Aboussad A, Chabaa L, Zeder C, Kippler M, Baumgartner J, Sedki A, Zimmermann MB. Effects of wheat-flour biscuits fortified with iron and EDTA, alone and in combination, on blood lead concentration, iron status, and cognition in children: a double-blind randomized controlled trial. Am J Clin Nutr. 2016 Nov;104(5):1318-1326. doi: 10.3945/ajcn.115.129346. Epub 2016 Oct 12.

    PMID: 27733396DERIVED

MeSH Terms

Conditions

Iron DeficienciesLead PoisoningMotor Activity

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHeavy Metal PoisoningPoisoningChemically-Induced DisordersBehavior

Study Officials

  • Michael B Zimmermann, Prof. Dr. med

    Swiss Federal Institute of Technology (ETH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med

Study Record Dates

First Submitted

November 8, 2011

First Posted

April 6, 2012

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

CH(1)