Clinical trial NCT03353662: Sub Regional Micronutrient Survey in Ethiopia
Official title: The Assessment of Sub-Regional Micronutrient Deficiencies in Ethiopia to Target Bio Fortification.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron-deficiency
Vitamin A Deficiency
Zinc Deficiency
Keywords: bio fortification
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: HarvestPlus
name: Addis Ababa University
First posted: 2017-11-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 5
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of Anaemia
timeFrame: March 2018
measure: Prevalence of Zinc deficiency
timeFrame: March 2018
measure: Prevalence of Vitamin A deficiency
timeFrame: March 2018
Secondary outcomes:
measure: Inflammation biomarkers
timeFrame: March 2018
measure: Anthropometric measurement - Height
timeFrame: March 2018
measure: Anthropometric measurement - Weight
timeFrame: March 2018
measure: Inflammation Biomarker
timeFrame: March 2018
Other outcomes:
Locations:
city: Addis Ababa
country: Ethiopia
facility: Center for Food Science and Nutrition, Addis Ababa University
city: Zurich
country: Switzerland
facility: Swiss Federal Institute of Technology (ETH)
Study officials:
affiliation: Professor and Head, Human Nutrition, Swiss Federal Institute of Technology (ETH) Zurich, Switzerland
name: Michael Zimmermann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia
name: Kaleab Baye, PhD
role: PRINCIPAL_INVESTIGATOR
References: