Sub Regional Micronutrient Survey in Ethiopia

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03353662
• Other study ID #: Ethiopia_SRMNS
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: June 2019

Study information

• Verified date: June 2018
• Source: Swiss Federal Institute of Technology
• Contact: Colin Cercamondi, PhD
• Phone: 0041 44632 86 34
• Email: colin.cercamondi[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency
• Night Blindness
• Vitamin A Deficiency
• Zinc Deficiency

Intervention

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 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 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 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 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 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.

Locations

Country	Name	City	State
Ethiopia	Center for Food Science and Nutrition, Addis Ababa University	Addis Ababa
Switzerland	Swiss Federal Institute of Technology (ETH)	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Addis Ababa University, HarvestPlus

Countries where clinical trial is conducted

Ethiopia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Anaemia	Prevalence of iron deficiency with or without anemia	March 2018
Primary	Prevalence of Zinc deficiency	Based on plasma Zinc concentration	March 2018
Primary	Prevalence of Vitamin A deficiency	Measuring Vitamin A biomarkers	March 2018
Secondary	Inflammation biomarkers	C reactive protein (CRP)	March 2018
Secondary	Anthropometric measurement - Height	height in cm	March 2018
Secondary	Anthropometric measurement - Weight	weight in Kg	March 2018
Secondary	Inflammation Biomarker	Alpha 1-acid glycoprotein (AGP)	March 2018