Iron-deficiencyNCT03355287
Iron Status in Infants in Ethiopia.
A study testing Traditionally Threshed Teff (TTT), Lab Threshed Teff (LTT) and Fortified Lab Threshed Teff (FTT) in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
Trial summary
To assess the impact of soil iron intake from teff flour on iron status in infants in Debre Zeit, Ethiopia. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Iron Deficiency Anemia, Aluminium Intoxication
- What is being tested?
- Traditionally Threshed Teff (TTT), Lab Threshed Teff (LTT) and Fortified Lab Threshed Teff (FTT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2018to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Ethiopia1 site
Center for Food Science and Nutrition, Addis Ababa University
Addis Ababa, 150201
Kaleab Baye, PhD, +251.911.890489, kaleabbaye@gmail.com
Switzerland1 site
Swiss Federal Institute of Technology ETH Zurich
Zurich, 8092
Colin Cercamondi, PhD, +41446328634, colin.cercamondi@hest.ethz.ch
Amrutha Anandaraman, MSc, +41446329341, amrutha.anandaraman@hest.ethz.ch
About this study
Official title: 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.
Read the 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.
- Being tested
- Traditionally Threshed Teff (TTT), Lab Threshed Teff (LTT), Fortified Lab Threshed Teff (FTT)
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Traditionally Threshed Teff (TTT) | Placebo comparator | 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. Receives: Other: Traditionally Threshed Teff (TTT) |
| Lab Threshed Teff (LTT) | Experimental | The intervention group will consume injera based on teff flour that has been lab threshed using a modern teff threshing machine. Receives: Other: Lab Threshed Teff (LTT) |
| Fortified Lab Threshed Teff (FTT) | Active comparator | 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. Receives: Other: Fortified Lab Threshed Teff (FTT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Haemoglobin
Iron status
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
Secondary outcomes (9)
Change in Aluminium (Al) levels
Measuring Al in plasma
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Through study completion, an average of 7 months
Teff flour
Phytate content
Measured: Through study completion, an average of 7 months
Morbidity
Any sickness arising due to the consumption of the meals
Measured: Through study completion, an average of 7 months
Injera consumption
Amount of injera consumed by the child in each meal
Measured: Through study completion, an average of 7 months
2 day weighted food record
To estimate the amount of different foods consumed by the child
Measured: Through study completion, an average of 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startNov 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University, HarvestPlus
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael Zimmermann, Dr. PhD, Principal investigator, Swiss Federal Institute of Technology, ETH Zurich, SwitzerlandKaleab Baye, PhD, Principal investigator, Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355287
- Sponsor's protocol ID
- Eth_Teff_Iron
- Status last verified
- Sep 2018
- First submitted
- 13 Nov 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Soil Iron Intake From Teff Flour on Iron Status in Infants in Ethiopia.
- ClinicalTrials.gov ID
- NCT03355287
- Acronym / sponsor ID
- Eth_Teff_Iron
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Addis Ababa University, HarvestPlus
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traditionally Threshed Teff (TTT) | Placebo comparator | Other: 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. |
| Lab Threshed Teff (LTT) | Experimental | Other: 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. |
| Fortified Lab Threshed Teff (FTT) | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Traditionally Threshed Teff (TTT) |
| 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 | Lab Threshed Teff (LTT) |
| 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 | Other | Fortified Lab Threshed Teff (FTT) |
Primary outcome
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
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
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
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
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
9 secondary outcomes
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 )
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)
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)
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)
Teff flour
Time frame: Through study completion, an average of 7 months
Teff flour
Time frame: Through study completion, an average of 7 months
Morbidity
Time frame: Through study completion, an average of 7 months
Injera consumption
Time frame: Through study completion, an average of 7 months
2 day weighted food record
Time frame: Through study completion, an average of 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zimmermann, Dr. PhD principal investigator
Swiss Federal Institute of Technology, ETH Zurich, Switzerland
Kaleab Baye, PhD principal investigator
Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditionally Threshed Teff (TTT), Lab Threshed Teff (LTT) and Fortified Lab Threshed Teff (FTT) in people with Iron-deficiency and Iron Deficiency Anemia, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin Cercamondi, PhD (+41 44 632 86 34, colin.cercamondi@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.