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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01573013
First received: November 8, 2011
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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 Intervention
Iron Deficiency
Lead Poisoning
Dietary Supplement: iron fortified biscuits

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • body lead burden [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    changes in blood lead levels over time of the intervention


Secondary Outcome Measures:
  • Iron status [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    changes in iron status (SF,Hb, TfR) before and after intervention

  • cognitive development [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    changes in cognitive development (using the K ABC II) before and after intervention


Enrollment: 457
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 13 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
  More Information

No publications provided

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
Study First Received: November 8, 2011
Last Updated: May 9, 2014
Health Authority: Switzerland: Ethikkommission
Morocco: Ministry of Public Health

Keywords provided by Swiss Federal Institute of Technology:
iron deficiency
Lead poisoning
cognitive development
motor activity

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

ClinicalTrials.gov processed this record on July 28, 2014