NCT03355287

Iron Status in Infants in Ethiopia.

Assessing the Impact of Soil Iron Intake From Teff Flour on Iron Status in Infants in Ethiopia.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 315 (estimated)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: All
• Age: 18 Months – 36 Months
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Iron-deficiency
• Iron Deficiency Anemia
• Aluminium Intoxication

Interventions

Type	Name	Description
OTHER	Traditionally Threshed Teff (TTT)	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
OTHER	Lab Threshed Teff (LTT)	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.
OTHER	Fortified Lab Threshed Teff (FTT)	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

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-06-01
• Completion: 2019-08-01
• First posted: 2017-11-28
• Last updated: 2018-09-05

Locations

2 sites across 2 countries: Ethiopia, Switzerland