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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

457 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Iron Status in Infants in Ethiopia.

NCT03355287

Iron-deficiency Iron Deficiency Anemia Aluminium Intoxication

UNKNOWN NA

Improving Iron Status Through Consumption Of Iron Fortified Cowpea: An Intervention Study

NCT01208363

Anemia Low Iron Stores

COMPLETED NA

Maximizing the Benefits of Iron in Ready-to-Use Therapeutic Foods for Malnourished Children in Kenya

NCT07315295

Iron Absorption Iron Deficiencies Severly Acutely Malnourished Children +2 more

RECRUITING NA

Iron Supplementation of Lead-exposed Infants

NCT00374790

Lead Toxicity

COMPLETED PHASE2

Safety of Various Mode of Delivery of Iron Supplement on Iron Toxicity Markers in Preschool Children

NCT00980421

Iron Overload Oxidative Stress

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Introduction Coexisting chronic lead poisoning and iron deficiency anemia (IDA) are common in urban areas in developing regions, particularly in young children. In urban Morocco, anemia affects more than 1/3rd of schoolchildren and lead exposure is high. Lead poisoning and IDA both impair cognitive development and educability and may therefore have substantial health, social and economic costs on developing countries.

Iron status alters susceptibility to gastrointestinal lead exposure; absorption of lead is sharply increased in children with IDA. IDA upregulates the divalent metal transporter trans-port protein (DMT-1) and increases lead absorption. Thus, iron fortification to reduce IDA may also reduce lead absorption and be an effective strategy to accompany environmental lead abatement. The optimal iron compound for wheat flour is currently debated, and although elemental iron compounds are commonly used, they may be only poorly absorbed in the face of inhibitory compounds found in wheat flour.

A form of chelated iron, NaFeEDTA, is a promising iron fortificant that is recommended for wheat flour fortification. It is also a lead chelator. It may be superior to other iron fortificants in its ability to reduce body lead burden, due to:

1. its iron is highly bioavailable in the face of dietary inhibitors (such as phytic acid in wheat flour); and
2. potentially, its ability to chelate lead in the gut and bloodstream. Thus, it may be a good choice for fortification of wheat flour in Morocco, particularly in urban areas, to both reduce IDA and lower body lead.

Study aims and objectives:

1. Assessment of body lead burden and iron status in a cohort of individuals residing in areas of presumed high lead exposure. Investigation of associations between lead burden and iron status.
2. Comparison of effect of iron fortification with and without NaEDTA on body lead and iron status in lead-exposed children; and the relative impact on cognition.

Study hypotheses:

The prevalence of iron deficiency and elevated blood lead will be high in children in this region.

2\) Body lead burden, as assessed by blood lead levels and urinary lead and delta-aminolevulinic acid (ALA), will be higher in individuals with poorer iron status.

3\) Poor iron status will be associated with low intakes of bioavailable iron. 4) Greater severity of iron deficiency and/or higher body lead in children will predict poorer performance on cognitive and motor tests, and these conditions will interact to predict poorer performance.

Study design:

Our studies will be carried out in one of the four sub-economic areas, that were previously used in the baseline assessment in and near Marrakesh, Morocco (exact site still needs to be determined according to extend of lead contamination on the level of human population). Body lead burden and iron status will be determined, and associations between these examined using a cross-sectional design. For this purpose, blood and urine samples will be collected from two groups (preschool and school-aged children), residing in an area of high lead exposure.

Study design:

An 8-month intervention study in iron deficient, lead-exposed school children (n=500) will be designed to investigate whether iron fortification to reduce IDA may also reduce lead absorption and be an effective strategy to accompany environmental lead abatement.

For this purpose these children will be divided into four groups to receive a daily fortified baked snack containing either: 1) 66.4 mg NaFeEDTA ; 2) 52.2 mg Na2EDTA dehydrate; 3) 27.1 mg FeSO4 ; or 4) no fortificants.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron Deficiency Lead Poisoning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.