Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children
This study has been completed.
Sponsor:
Swiss Federal Institute of Technology
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: November 16, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- iron status measures [ Time Frame: 8 months ] [ Designated as safety issue: No ]changes in iron status (Hb, SF, TfR)before and after intervention
Secondary Outcome Measures:
- Body lead burden [ Time Frame: 8 months ] [ Designated as safety issue: No ]changes in blood lead levels 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: | 453 |
| 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 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
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: | November 16, 2012 |
| 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 June 18, 2013