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Iron Status in Infants in Ethiopia.

Primary Purpose

Iron-deficiency, Iron Deficiency Anemia, Aluminium Intoxication

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Traditionally Threshed Teff (TTT)
Lab Threshed Teff (LTT)
Fortified Lab Threshed Teff (FTT)
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron-deficiency

Eligibility Criteria

18 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for Food Science and Nutrition, Addis Ababa University
  • Swiss Federal Institute of Technology ETH Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Traditionally Threshed Teff (TTT)

Lab Threshed Teff (LTT)

Fortified Lab Threshed Teff (FTT)

Arm Description

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.

The intervention group will consume injera based on teff flour that has been lab threshed using a modern teff threshing machine.

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.

Outcomes

Primary Outcome Measures

Change in Haemoglobin
Iron status
Change in Ferritin
Iron status
Change in Soluble Transferrin Receptor (sTfR)
Iron status
Change in C-Reactive Protein (CRP)
Inflammation
Change in Alpha 1-Acid Glycoprotein (AGP)
Inflammation

Secondary Outcome Measures

Change in Aluminium (Al) levels
Measuring Al in plasma
Change in Aluminium (Al) levels
Measuring Al in hair and nail
Change in Anthropometric measurements
Weight in kg
Change in Anthropometric measurements
Height in cm
Teff flour
Iron concentration
Teff flour
Phytate content
Morbidity
Any sickness arising due to the consumption of the meals
Injera consumption
Amount of injera consumed by the child in each meal
2 day weighted food record
To estimate the amount of different foods consumed by the child

Full Information

First Posted
November 13, 2017
Last Updated
September 3, 2018
Sponsor
Swiss Federal Institute of Technology
Collaborators
Addis Ababa University, HarvestPlus
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1. Study Identification

Unique Protocol Identification Number
NCT03355287
Brief Title
Iron Status in Infants in Ethiopia.
Official Title
Assessing the Impact of Soil Iron Intake From Teff Flour on Iron Status in Infants in Ethiopia.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2018 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Addis Ababa University, HarvestPlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency, Iron Deficiency Anemia, Aluminium Intoxication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
315 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditionally Threshed Teff (TTT)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Lab Threshed Teff (LTT)
Arm Type
Experimental
Arm Description
The intervention group will consume injera based on teff flour that has been lab threshed using a modern teff threshing machine.
Arm Title
Fortified Lab Threshed Teff (FTT)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Traditionally Threshed Teff (TTT)
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Lab Threshed Teff (LTT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Fortified Lab Threshed Teff (FTT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Haemoglobin
Description
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)
Title
Change in Ferritin
Description
Iron status
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 )
Title
Change in Soluble Transferrin Receptor (sTfR)
Description
Iron status
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 )
Title
Change in C-Reactive Protein (CRP)
Description
Inflammation
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 )
Title
Change in Alpha 1-Acid Glycoprotein (AGP)
Description
Inflammation
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 )
Secondary Outcome Measure Information:
Title
Change in Aluminium (Al) levels
Description
Measuring Al in plasma
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 )
Title
Change in Aluminium (Al) levels
Description
Measuring Al in hair and nail
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)
Title
Change in Anthropometric measurements
Description
Weight in kg
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)
Title
Change in Anthropometric measurements
Description
Height in cm
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)
Title
Teff flour
Description
Iron concentration
Time Frame
Through study completion, an average of 7 months
Title
Teff flour
Description
Phytate content
Time Frame
Through study completion, an average of 7 months
Title
Morbidity
Description
Any sickness arising due to the consumption of the meals
Time Frame
Through study completion, an average of 7 months
Title
Injera consumption
Description
Amount of injera consumed by the child in each meal
Time Frame
Through study completion, an average of 7 months
Title
2 day weighted food record
Description
To estimate the amount of different foods consumed by the child
Time Frame
Through study completion, an average of 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Colin Cercamondi, PhD
Phone
+41 44 632 86 34
Email
colin.cercamondi@hest.ethz.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Amrutha Anandaraman, MSc
Phone
+41 44 832 93 41
Email
amrutha.anandaraman@hest.ethz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Zimmermann, Dr. PhD
Organizational Affiliation
Swiss Federal Institute of Technology, ETH Zurich, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kaleab Baye, PhD
Organizational Affiliation
Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Food Science and Nutrition, Addis Ababa University
City
Addis Ababa
ZIP/Postal Code
150201
Country
Ethiopia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaleab Baye, PhD
Phone
+251.911.890489
Email
kaleabbaye@gmail.com
Facility Name
Swiss Federal Institute of Technology ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colin Cercamondi, PhD
Phone
+41446328634
Email
colin.cercamondi@hest.ethz.ch
First Name & Middle Initial & Last Name & Degree
Amrutha Anandaraman, MSc
Phone
+41446329341
Email
amrutha.anandaraman@hest.ethz.ch
First Name & Middle Initial & Last Name & Degree
Michael Zimmermann, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Iron Status in Infants in Ethiopia.

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