Sub Regional Micronutrient Survey in Ethiopia

• Conditions: Iron-deficiency; Vitamin A Deficiency; Zinc Deficiency
• Interventions: Other: Women of Gamo Gofa; Other: Women of West Gojjam; Other: Children of West Gojjam; Other: Women of Kamashi; Other: Children of Kamashi; Other: Children of Gamo Gofa

• Registration Number: NCT03353662
• Lead Sponsor: Swiss Federal Institute of Technology

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-27
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-20
• Last Update Posted: 2018-06-21
• Study Start: 2018-09
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women of Gamo Gofa	Women of Gamo Gofa	The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Gamo Gofa between 15-49 years
Women of West Gojjam	Women of West Gojjam	The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of West Gojjam between 15-49 years
Children of West Gojjam	Children of West Gojjam	The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of West Gojjam between 6 - 59 months
Women of Kamashi	Women of Kamashi	The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Kamashi between 15-49 years
Children of Kamashi	Children of Kamashi	The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Kamashi between 6 - 59 months
Children of Gamo Gofa	Children of Gamo Gofa	The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Gamo Gofa between 6 - 59 months

Primary Outcome Measures

Name	Time	Method
Prevalence of Vitamin A deficiency	March 2018	Measuring Vitamin A biomarkers
Prevalence of Anaemia	March 2018	Prevalence of iron deficiency with or without anemia
Prevalence of Zinc deficiency	March 2018	Based on plasma Zinc concentration

Secondary Outcome Measures

Name	Time	Method
Inflammation biomarkers	March 2018	C reactive protein (CRP)
Anthropometric measurement - Height	March 2018	height in cm
Anthropometric measurement - Weight	March 2018	weight in Kg
Inflammation Biomarker	March 2018	Alpha 1-acid glycoprotein (AGP)

Trial Locations

Locations (2)

Center for Food Science and Nutrition, Addis Ababa University; 🇪🇹 Addis Ababa, Ethiopia

Swiss Federal Institute of Technology (ETH); 🇨🇭 Zurich, Switzerland