Iron Status in Infants in Ethiopia.

Swiss Federal Institute of Technology315 enrolled

Overview

To assess the impact of soil iron intake from teff flour on iron status in infants in Debre Zeit, Ethiopia.

Rationale: Teff (Eragrostis Teff), a major staple crop in several areas of Ethiopia, is of special relevance to Fe biofortifcation as it provides the population with a regular high consumption of contaminant soil Fe due to the traditional threshing procedure under the hooves of the cattle. The bioavailability of soil Fe, and hence its contribution to Fe requirements, is unknown. Data on the bioavailability of soil Fe would clarify to what extent the soil Fe can be considered as a source of absorbable Fe. This information is important in order to establish dietary advice and is essential for the development of iron biofortification (and fortification) policies related to Fe nutrition in Ethiopia. Objective: The overall objective of the project is to generate data to target and tailor biofortification approaches in Ethiopia by an intervention trial assessing the impact of soil Fe intake from teff consumption on Fe status. Study design: The intervention trial will be a 7 months partially blinded, randomized control trial (RCT) with the following three arms: control-group consuming injera based on traditionally threshed teff (average Fe content 50 mg/100g flour), 2) intervention group consuming injera based on lab-threshed teff (average Fe content 6.65 mg/100g flour), 3) positive control group consuming the lab-threshed teff together with ferrous sulphate iron drops (additional Fe from the drops = 6 mg). Study population: 315 children between 18-36 months of age living in Debre Zeit and surrounding areas will be enrolled. Main study parameters/endpoints: The impact of soil Fe in teff on Fe status will be assessed by measuring the Fe status, prevalence of Fe deficiency and Fe deficiency anemia at baseline, midpoint and endpoint. To assess Fe status, Hemoglobin (Hb), Plasma Ferritin (PF), Soluble Transferrin Receptor (sTfR), C- Reactive Protein(CRP) and Alpha 1B glycoprotein (AGP) will be determined.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

315

Conditions

Iron-deficiency Iron Deficiency Anemia Aluminium Intoxication

Interventions

Traditionally Threshed Teff (TTT)OTHER

The intervention will take place for 7 months in Debre Zeit where the the arm will be fed injera based on teff that are threshed traditionally

Lab Threshed Teff (LTT)OTHER

The intervention will take place for 7 months in Debre Zeit where this arm will be fed injera from teff that is threshed using a modern thresher.

Fortified Lab Threshed Teff (FTT)OTHER

The intervention will take place for 7 months in Debre Zeit where this arm will be fed injera from teff that is threshed using a modern thresher. In addition, they will receive Ferrous sulfate drops

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18-36 months of age (at screening) * The child is able to eat at least two injera meals per day * The informed consent form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy) Exclusion Criteria: * Severely deficient in Hb (\<70g/L) * Severe underweight (weight for age Z score \< -3), * Severe wasting (weight for height Z score \< -3) * Chronic or acute illness or other conditions that in the opinion of the Principle Investigator (PI) or co-researchers would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol * Participants taking part in other studies requiring the drawing of blood * Not planning long-term residence in study site

Locations (2)

Center for Food Science and Nutrition, Addis Ababa University

Addis Ababa, Ethiopia

Swiss Federal Institute of Technology ETH Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Change in Haemoglobin

Iron status

Time frame: Three collection points - First collection point at screening, second collection point at mid point (3.5 months after start of intervention) and third collection point at the end point ( end of the 7 months of the intervention)

Change in Ferritin

Iron status