Assessing the Impact of Soil Iron Intake From Teff Flour on Iron Status in Infants in Ethiopia.
试验速览
- 阶段
- 不适用
- 入组人数
- 315
- 试验地点
- 4
- 主要终点
- Change in Alpha 1-Acid Glycoprotein (AGP)
研究概览
简要总结
To assess the impact of soil iron intake from teff flour on iron status in infants in Debre Zeit, Ethiopia.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Traditionally Threshed Teff (TTT) (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.
干预措施: Lab Threshed Teff (LTT) (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.
干预措施: Fortified Lab Threshed Teff (FTT) (Other)
结局指标
主要结局
Change in Alpha 1-Acid Glycoprotein (AGP)
时间窗: 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 Ferritin
时间窗: 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)
时间窗: 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)
时间窗: 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 Haemoglobin
时间窗: 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
次要结局
- Morbidity(Through study completion, an average of 7 months)
- Injera consumption(Through study completion, an average of 7 months)
- Change in Aluminium (Al) levels(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))
- 2 day weighted food record(Through study completion, an average of 7 months)
- 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))
- Teff flour(Through study completion, an average of 7 months)
研究者
Prof. Michael B. Zimmermann
Dr.Prof.
Swiss Federal Institute of Technology