Iron Status in Infants in Ethiopia.

• ClinicalTrials.gov Identifier: NCT03355287
• Recruitment Status: Unknown
• First Posted: November 28, 2017
• Last Update Posted: September 5, 2018
• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Addis Ababa University; HarvestPlus
• Information provided by (Responsible Party): Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Iron-deficiency; Iron Deficiency Anemia; Aluminium Intoxication	Other: Traditionally Threshed Teff (TTT); Other: Lab Threshed Teff (LTT); Other: Fortified Lab Threshed Teff (FTT)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 315 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Assessing the Impact of Soil Iron Intake From Teff Flour on Iron Status in Infants in Ethiopia.
• Estimated Study Start Date: November 2018
• Estimated Primary Completion Date: June 2019
• Estimated Study Completion Date: August 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Haemoglobin [ 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) ]
   Iron status
2. Change in Ferritin [ Time Frame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start ) ]
   Iron status
3. Change in Soluble Transferrin Receptor (sTfR) [ Time Frame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start ) ]
   Iron status
4. Change in C-Reactive Protein (CRP) [ Time Frame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start ) ]
   Inflammation
5. Change in Alpha 1-Acid Glycoprotein (AGP) [ Time Frame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start ) ]
   Inflammation

Secondary Outcome Measures :

1. Change in Aluminium (Al) levels [ Time Frame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start ) ]
   Measuring Al in plasma
2. Change in Aluminium (Al) levels [ Time Frame: 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) ]
   Measuring Al in hair and nail
3. Change in Anthropometric measurements [ Time Frame: 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) ]
   Weight in kg
4. Change in Anthropometric measurements [ Time Frame: 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) ]
   Height in cm
5. Teff flour [ Time Frame: Through study completion, an average of 7 months ]
   Iron concentration
6. Teff flour [ Time Frame: Through study completion, an average of 7 months ]
   Phytate content
7. Morbidity [ Time Frame: Through study completion, an average of 7 months ]
   Any sickness arising due to the consumption of the meals
8. Injera consumption [ Time Frame: Through study completion, an average of 7 months ]
   Amount of injera consumed by the child in each meal
9. 2 day weighted food record [ Time Frame: Through study completion, an average of 7 months ]
   To estimate the amount of different foods consumed by the child

Eligibility Criteria

• Ages Eligible for Study: 18 Months to 36 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: Colin Cercamondi, PhD; +41 44 632 86 34; colin.cercamondi@hest.ethz.ch

Contact: Amrutha Anandaraman, MSc; +41 44 832 93 41; amrutha.anandaraman@hest.ethz.ch

Locations

Ethiopia

Center for Food Science and Nutrition, Addis Ababa University

Addis Ababa, Ethiopia, 150201

Contact: Kaleab Baye, PhD +251.911.890489 kaleabbaye@gmail.com

Switzerland

Swiss Federal Institute of Technology ETH Zurich

Zurich, Switzerland, 8092

Contact: Colin Cercamondi, PhD +41446328634 colin.cercamondi@hest.ethz.ch

Contact: Amrutha Anandaraman, MSc +41446329341 amrutha.anandaraman@hest.ethz.ch

Principal Investigator: Michael Zimmermann, PhD

Sponsors and Collaborators

Swiss Federal Institute of Technology

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

More Information

• Responsible Party: Prof. Michael B. Zimmermann, Dr.Prof., Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT03355287
• Other Study ID Numbers: Eth_Teff_Iron
• First Posted: November 28, 2017
• Last Update Posted: September 5, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Anemia, Iron-Deficiency; Anemia, Hypochromic; Anemia; Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases