The Assessment of Sub-Regional Micronutrient Deficiencies in Ethiopia to Target Bio Fortification.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Prevalence of Vitamin A deficiency
研究概览
简要总结
To conduct a sub-regional micronutrient survey (SRMNS) assessing the prevalence of vitamin A, Zn, and Fe status in the country
详细描述
Background: In Ethiopia, biofortified staple crops, such as high vitamin A maize, high zinc (Zn) maize, high Zn wheat and high iron (Fe) common bean could have a beneficial impact on micronutrient status, as the regular varieties of these crops are eaten in significant amounts in some of the administrative regions. It is however, unknown in which region people would most benefit as data on vitamin A, Zn and Fe status in the different regions is too limited to efficiently target specific biofortification approaches.
Objective: The overall objective of the project is to generate data to target and tailor bio fortification approaches in Ethiopia. Therefore, it is planned to conduct a sub-regional micronutrient surveys (SRMNS) assessing the prevalence of vitamin A, Zn, and Fe status in the country.
Study design: The sub regional micronutrient survey (SRMNS) will have a cross-sectional design with one measuring point.
Study population: The SRMNS will be conducted in 600 children < 5 years of age and 600 women of reproductive age (18-45 years) living in the regions of Kamashi in Benishangul Gumuz, West Gojjam in Amhara, and Goma Gofa in Southern Nations, Nationalities and People's Regions (SNNP).
Main study parameters/endpoints: The prevalence of Fe, Zn and vitamin A deficiency will be assessed by measuring hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protocol (CRP), alpha-1-acid glycoprotein (AGP), plasma Zn (PZn), plasma retinol and retinol binding protein (RBP), respectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 5 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •5-59 months of age for children
- •15-49 years for women of reproductive age.
- •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 wasted and underweight children (weight for height and weight for age Z score < -3, respectively)
- •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
- •Long-term medication (except contraceptives for women of reproductive age)
- •Any severe metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement or examination of study doctor). Health records to be checked for the same.
- •Blood losses (surgery, accident), donations or transfusions during the past 4 months before study start.
结局指标
主要结局
Prevalence of Vitamin A deficiency
时间窗: March 2018
Measuring Vitamin A biomarkers
Prevalence of Anaemia
时间窗: March 2018
Prevalence of iron deficiency with or without anemia
Prevalence of Zinc deficiency
时间窗: March 2018
Based on plasma Zinc concentration
次要结局
- Inflammation biomarkers(March 2018)
- Anthropometric measurement - Height(March 2018)
- Anthropometric measurement - Weight(March 2018)
- Inflammation Biomarker(March 2018)
研究者
Prof. Michael B. Zimmermann
Professor and Head of Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich
Swiss Federal Institute of Technology