Iron Status in Infants in Ethiopia.

Iron Deficiency Anemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03355287
• Other study ID #: Eth_Teff_Iron
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: August 2019

Study information

• Verified date: September 2018
• Source: Swiss Federal Institute of Technology
• Contact: Colin Cercamondi, PhD
• Phone: +41 44 632 86 34
• Email: colin.cercamondi[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 315
• Est. completion date: August 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Aluminium Intoxication
• Anemia, Iron-Deficiency
• Iron Deficiency Anemia
• Iron-deficiency

Intervention

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
• 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.
• 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

Locations

Country	Name	City	State
Ethiopia	Center for Food Science and Nutrition, Addis Ababa University	Addis Ababa
Switzerland	Swiss Federal Institute of Technology ETH Zurich	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Addis Ababa University, HarvestPlus

Countries where clinical trial is conducted

Ethiopia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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 )
Primary	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 )
Primary	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 )
Primary	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	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 )
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Teff flour	Iron concentration	Through study completion, an average of 7 months
Secondary	Teff flour	Phytate content	Through study completion, an average of 7 months
Secondary	Morbidity	Any sickness arising due to the consumption of the meals	Through study completion, an average of 7 months
Secondary	Injera consumption	Amount of injera consumed by the child in each meal	Through study completion, an average of 7 months
Secondary	2 day weighted food record	To estimate the amount of different foods consumed by the child	Through study completion, an average of 7 months