Sub Regional Micronutrient Survey in Ethiopia

Federal Institute of Technology (ETH) Zurich

Status: Unknown

Conditions: Iron-deficiency; Vitamin A Deficiency; Zinc Deficiency

Treatments: Other: Children of Gamo Gofa; Other: Women of Kamashi; Other: Women of Gamo Gofa; Other: Children of West Gojjam; Other: Children of Kamashi; Other: Women of West Gojjam

Study type: Observational

Funder types: Other

Identifiers

NCT03353662

Ethiopia_SRMNS

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 5 months to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

1,200 participants in 6 patient groups

Women of Gamo Gofa

Description:

The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Gamo Gofa between 15-49 years

Treatment:

Other: Women of Gamo Gofa

Children of Gamo Gofa

Description:

The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Gamo Gofa between 6 - 59 months

Treatment:

Other: Children of Gamo Gofa

Women of West Gojjam

Description:

The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of West Gojjam between 15-49 years

Treatment:

Other: Women of West Gojjam

Children of West Gojjam

Description:

The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of West Gojjam between 6 - 59 months

Treatment:

Other: Children of West Gojjam

Women of Kamashi

Description:

The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Kamashi between 15-49 years

Treatment:

Other: Women of Kamashi

Children of Kamashi

Description:

The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Kamashi between 6 - 59 months

Treatment:

Other: Children of Kamashi