Iron Status in Infants in Ethiopia.

Federal Institute of Technology (ETH) Zurich

Status: Unknown

Conditions: Iron Deficiency Anemia; Iron-deficiency; Aluminium Intoxication

Treatments: Other: Traditionally Threshed Teff (TTT); Other: Lab Threshed Teff (LTT); Other: Fortified Lab Threshed Teff (FTT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03355287

Eth_Teff_Iron

Details and patient eligibility

About

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

Full 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.

Enrollment: 315 estimated patients

Sex: All

Ages: 18 to 36 months old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

315 participants in 3 patient groups, including a placebo group

Traditionally Threshed Teff (TTT)

Placebo Comparator group

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.

Treatment:

Other: Traditionally Threshed Teff (TTT)

Lab Threshed Teff (LTT)

Experimental group

Description:

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

Treatment:

Other: Lab Threshed Teff (LTT)

Fortified Lab Threshed Teff (FTT)

Active Comparator group

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.

Treatment:

Other: Fortified Lab Threshed Teff (FTT)