Sub Regional Micronutrient Survey in Ethiopia

Study Overview
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Brief Summary
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To conduct a sub-regional micronutrient survey (SRMNS) assessing the prevalence of vitamin A, Zn, and Fe status in the country

Detailed Description
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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. Significance: The study will generate important data on the vitamin A, Zn and Fe status of children and women for sub-regions in Ethiopia. Such sub-regional data will be more specific than common survey data and therefore be helpful to target bio fortification and identify the populations in Ethiopia who will benefit most from high nutrient crops.

Official Title
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The Assessment of Sub-Regional Micronutrient Deficiencies in Ethiopia to Target Bio Fortification.

Conditions
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Iron-deficiency, Vitamin A Deficiency, Zinc Deficiency

Intervention / Treatment
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* Other: Women of Gamo Gofa
* Other: Children of Gamo Gofa
* Other: Women of West Gojjam
* Other: Children of West Gojjam
* Other: Women of Kamashi
* Other: Children of Kamashi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women of Gamo Gofa<br>The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Gamo Gofa between 15-49 years | Other: Women of Gamo Gofa<br>* The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Gamo Gofa between 15-49 years 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.<br>|
| Children of Gamo Gofa<br>The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Gamo Gofa between 6 - 59 months | Other: Children of Gamo Gofa<br>* The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Gamo Gofa between 6-59 months 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.<br>|
| Women of West Gojjam<br>The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of West Gojjam between 15-49 years | Other: Women of West Gojjam<br>* The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of West Gojjam between 15-49 years 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.<br>|
| Children of West Gojjam<br>The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of West Gojjam between 6 - 59 months | Other: Children of West Gojjam<br>* The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of West Gojjam between the age of 6-59 months 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.<br>|
| Women of Kamashi<br>The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Kamashi between 15-49 years | Other: Women of Kamashi<br>* The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Kamashi between 15-49 years 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.<br>|
| Children of Kamashi<br>The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Kamashi between 6 - 59 months | Other: Children of Kamashi<br>* The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Kamashi between 6-59 months 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Anaemia | Prevalence of iron deficiency with or without anemia | March 2018 | 
| Prevalence of Zinc deficiency | Based on plasma Zinc concentration | March 2018 | 
| Prevalence of Vitamin A deficiency | Measuring Vitamin A biomarkers | March 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation biomarkers | C reactive protein (CRP) | March 2018 | 
| Anthropometric measurement - Height | height in cm | March 2018 | 
| Anthropometric measurement - Weight | weight in Kg | March 2018 | 
| Inflammation Biomarker | Alpha 1-acid glycoprotein (AGP) | March 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bio fortification