Iron Status in Infants in Ethiopia.

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

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

Study Overview

• Status: Unknown
• Conditions: Iron-deficiency; Iron Deficiency Anemia; Aluminium Intoxication
• Intervention / Treatment: Other: Traditionally Threshed Teff (TTT); Other: Lab Threshed Teff (LTT); Other: Fortified Lab Threshed Teff (FTT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 315
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Colin Cercamondi, PhD; Phone Number: +41 44 632 86 34; Email: colin.cercamondi@hest.ethz.ch
• Study Contact Backup: Name: Amrutha Anandaraman, MSc; Phone Number: +41 44 832 93 41; Email: amrutha.anandaraman@hest.ethz.ch

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia, 150201
    • Center for Food Science and Nutrition, Addis Ababa University
    • Contact: Kaleab Baye, PhD; Phone Number: +251.911.890489; Email: kaleabbaye@gmail.com
• Switzerland
  • Zurich, Switzerland, 8092
    • Swiss Federal Institute of Technology ETH Zurich
    • Contact: Colin Cercamondi, PhD; Phone Number: +41446328634; Email: colin.cercamondi@hest.ethz.ch
    • Contact: Amrutha Anandaraman, MSc; Phone Number: +41446329341; Email: amrutha.anandaraman@hest.ethz.ch
    • Principal Investigator: Michael Zimmermann, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Traditionally Threshed Teff (TTT); The control group will consume injera based on teff threshed under the hooves of cattle. We plan to have a certain number of teff flour suppliers, where the teff is traditionally threshed and contains at least 50 mg Fe per 100 g flour.	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
Experimental: Lab Threshed Teff (LTT); The intervention group will consume injera based on teff flour that has been lab threshed using a modern teff threshing machine.	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.
Active Comparator: Fortified Lab Threshed Teff (FTT); This arm will be the positive control group consuming Ferrous Sulphate drops ( with injera that consist of lab-threshed teff. The Fe drops have to be consumed with the meal and will provide an additional 6 mg of Ferrous sulfate to the diet of the children.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Haemoglobin	Iron status	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	Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
Change in Soluble Transferrin Receptor (sTfR)	Iron status	Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
Change in C-Reactive Protein (CRP)	Inflammation	Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
Change in Alpha 1-Acid Glycoprotein (AGP)	Inflammation	Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Aluminium (Al) levels	Measuring Al in plasma	Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
Change in Aluminium (Al) levels	Measuring Al in hair and nail	Three collection points - First collection point at the first day of the study, Second collection point during mid point ( 3.5 months after start of the intervention, and third collection point at the end of the intervention ( end of 7th month)
Change in Anthropometric measurements	Weight in kg	Three collection points - First collection point during screening, Second collection point during mid point ( 3.5 months after start of the intervention, and third collection point at the end of the intervention ( end of 7th month)
Change in Anthropometric measurements	Height in cm	Three collection points - First collection point during screening, Second collection point during mid point ( 3.5 months after start of the intervention, and third collection point at the end of the intervention ( end of 7th month)
Teff flour	Iron concentration	Through study completion, an average of 7 months
Teff flour	Phytate content	Through study completion, an average of 7 months
Morbidity	Any sickness arising due to the consumption of the meals	Through study completion, an average of 7 months
Injera consumption	Amount of injera consumed by the child in each meal	Through study completion, an average of 7 months
2 day weighted food record	To estimate the amount of different foods consumed by the child	Through study completion, an average of 7 months

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Addis Ababa University; HarvestPlus
• Investigators: Principal Investigator: Michael Zimmermann, Dr. PhD, Swiss Federal Institute of Technology, ETH Zurich, Switzerland; Principal Investigator: Kaleab Baye, PhD, Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): August 1, 2019

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): September 5, 2018
• Last Update Submitted That Met QC Criteria: September 3, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: Eth_Teff_Iron

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No