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

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ClinicalTrials.gov Identifier: NCT01573013
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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.


Condition or disease Intervention/treatment Phase
Iron Deficiency Lead Poisoning Dietary Supplement: iron fortified biscuits Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 457 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Interactions of Lead Intoxication and Iron Deficiency in Morocco: The Effects of Iron Fortification With and Without NaEDTA on Lead Burden, Iron Status and Cognition in Children
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Lead Poisoning
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: NaFeEDTA treatment, biscuit
Group receives 10 mg of Fe in form of NaFeEDTA per day. wheat flour based biscuit
Dietary Supplement: iron fortified biscuits
10 mg of iron per day for 8 months, either in the form of NaFeEDTA
Active Comparator: EDTA treatment, biscuit
Group receives Na2EDTA enriched biscuit
Dietary Supplement: iron fortified biscuits
EDTA fortified biscuit on a daily basis for 8 months
Active Comparator: FeSO4 treatment, biscuit
Group receives 10 mg of iron as FeSo4 per day for 8 months
Dietary Supplement: iron fortified biscuits
10 mg of iron per day for 8 months, in the form of FeSo4
Placebo Comparator: control treatment, biscuit
group receives a biscuit without additional iron
Dietary Supplement: iron fortified biscuits
control biscuit on a daily basis for 8 months



Primary Outcome Measures :
  1. body lead burden [ Time Frame: 8 months ]
    changes in blood lead levels over time of the intervention


Secondary Outcome Measures :
  1. Iron status [ Time Frame: 8 months ]
    changes in iron status (SF,Hb, TfR) before and after intervention

  2. cognitive development [ Time Frame: 8 months ]
    changes in cognitive development (using the K ABC II) before and after intervention



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Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • chronic or severe illnesses
  • history of bleeding disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573013


Locations
Switzerland
Swiss Federal Institute of Technology (ETH)
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
Investigators
Principal Investigator: Michael B Zimmermann, Prof. Dr. med Swiss Federal Institute of Technology (ETH)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr. med, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01573013     History of Changes
Other Study ID Numbers: IZ70Z0_123902
IZ70Z0_123902 ( Other Grant/Funding Number: The Swiss National Science Foundation (SNSF)/Project Nr. IZ70Z0_123902 )
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: May 2014

Keywords provided by Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology:
iron deficiency
Lead poisoning
cognitive development
motor activity

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Poisoning
Lead Poisoning
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Chemically-Induced Disorders
Iron
Fe(III)-EDTA
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action