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Sub Regional Micronutrient Survey in Ethiopia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03353662
Enrollment
1200
Registered
2017-11-27
Start date
2018-09-30
Completion date
2019-06-30
Last updated
2018-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency, Vitamin A Deficiency, Zinc Deficiency

Keywords

bio fortification

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.

Interventions

OTHERWomen 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.

OTHERChildren 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.

OTHERWomen 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.

OTHERChildren 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.

OTHERWomen 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.

OTHERChildren 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.

Sponsors

HarvestPlus
CollaboratorOTHER
Addis Ababa University
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Months to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of AnaemiaMarch 2018Prevalence of iron deficiency with or without anemia
Prevalence of Zinc deficiencyMarch 2018Based on plasma Zinc concentration
Prevalence of Vitamin A deficiencyMarch 2018Measuring Vitamin A biomarkers

Secondary

MeasureTime frameDescription
Inflammation biomarkersMarch 2018C reactive protein (CRP)
Inflammation BiomarkerMarch 2018Alpha 1-acid glycoprotein (AGP)
Anthropometric measurement - HeightMarch 2018height in cm
Anthropometric measurement - WeightMarch 2018weight in Kg

Countries

Ethiopia, Switzerland

Contacts

Primary ContactColin Cercamondi, PhD
colin.cercamondi@hest.ethz.ch0041 44632 86 34
Backup ContactAmrutha Anandaraman, MSc
amrutha.anandaraman@hest.ethz.ch0041 44632 93 41

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026