Aluminium Intoxication, Iron-deficiency, Iron Deficiency Anemia
Conditions
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.
Interventions
OTHERTraditionally 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
OTHERLab 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.
OTHERFortified 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
Sponsors
Addis Ababa University
HarvestPlus
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 36 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Haemoglobin | 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 | 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) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Aluminium (Al) levels | 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 day weighted food record | Through study completion, an average of 7 months | To estimate the amount of different foods consumed by the child |
| Change in Anthropometric measurements | 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 |
| Teff flour | Through study completion, an average of 7 months | Iron concentration |
| Morbidity | Through study completion, an average of 7 months | Any sickness arising due to the consumption of the meals |
| Injera consumption | Through study completion, an average of 7 months | Amount of injera consumed by the child in each meal |
Countries
Ethiopia, Switzerland
Contacts
Primary ContactColin Cercamondi, PhD
Backup ContactAmrutha Anandaraman, MSc
Outcome results
None listed