Sub Regional Micronutrient Survey in Ethiopia

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

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

Study Overview

• Status: Unknown
• Conditions: Iron-deficiency; Vitamin A Deficiency; Zinc Deficiency
• Intervention / Treatment: 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

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia, 150201
    • Center for Food Science and Nutrition, Addis Ababa University
• Switzerland
  • Zurich, Switzerland, 9092
    • Swiss federal institute of Technology (ETH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 49 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

households that have a woman of reproductive age (15-49 yrs) and children between 5- 59 months of age will be chosen to be a part of the study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: 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 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.
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	Other: 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 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.
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	Other: 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 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.
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	Other: Children of West Gojjam; 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.
Women of Kamashi; 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; 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.
Children of Kamashi; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Addis Ababa University; HarvestPlus
• Investigators: Principal Investigator: Kaleab Baye, PhD, Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia; Principal Investigator: Michael Zimmermann, PhD, Professor and Head, Human Nutrition, Swiss Federal Institute of Technology (ETH) Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 20, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: bio fortification
• Additional Relevant MeSH Terms: Eye Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vision Disorders; Night Blindness; Vitamin A Deficiency
• Other Study ID Numbers: Ethiopia_SRMNS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No