Clinical trial NCT03355287: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Iron-deficiency
Iron Deficiency Anemia
Aluminium Intoxication
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Addis Ababa University
name: HarvestPlus
First posted: 2017-11-28
Enrollment: 315
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Haemoglobin
timeFrame: 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)
measure: Change in Ferritin
timeFrame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
measure: Change in Soluble Transferrin Receptor (sTfR)
timeFrame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
measure: Change in C-Reactive Protein (CRP)
timeFrame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
measure: Change in Alpha 1-Acid Glycoprotein (AGP)
timeFrame: 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:
measure: Change in Aluminium (Al) levels
timeFrame: Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )
measure: Change in Aluminium (Al) levels
timeFrame: 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)
measure: Change in Anthropometric measurements
timeFrame: 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)
measure: Change in Anthropometric measurements
timeFrame: 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)
measure: Teff flour
timeFrame: Through study completion, an average of 7 months
measure: Teff flour
timeFrame: Through study completion, an average of 7 months
measure: Morbidity
timeFrame: Through study completion, an average of 7 months
measure: Injera consumption
timeFrame: Through study completion, an average of 7 months
measure: 2 day weighted food record
timeFrame: Through study completion, an average of 7 months
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Center for Food Science and Nutrition, Addis Ababa University
city: Zurich
country: Switzerland
facility: Swiss Federal Institute of Technology ETH Zurich
Study officials:
affiliation: Swiss Federal Institute of Technology, ETH Zurich, Switzerland
name: Michael Zimmermann, Dr. PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia
name: Kaleab Baye, PhD
role: PRINCIPAL_INVESTIGATOR
References: