Sub Regional Micronutrient Survey in Ethiopia

Sponsor
Swiss Federal Institute of Technology (Other)
Overall Status
Unknown status
CT.gov ID
NCT03353662
Collaborator
HarvestPlus (Other), Addis Ababa University (Other)
1,200
2
9
600
66.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Assessment of Sub-Regional Micronutrient Deficiencies in Ethiopia to Target Bio Fortification.
Anticipated Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Jun 1, 2019

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Prevalence of Anaemia [March 2018]

    Prevalence of iron deficiency with or without anemia

  2. Prevalence of Zinc deficiency [March 2018]

    Based on plasma Zinc concentration

  3. Prevalence of Vitamin A deficiency [March 2018]

    Measuring Vitamin A biomarkers

Secondary Outcome Measures

  1. Inflammation biomarkers [March 2018]

    C reactive protein (CRP)

  2. Anthropometric measurement - Height [March 2018]

    height in cm

  3. Anthropometric measurement - Weight [March 2018]

    weight in Kg

  4. Inflammation Biomarker [March 2018]

    Alpha 1-acid glycoprotein (AGP)

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Months to 49 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Food Science and Nutrition, Addis Ababa University Addis Ababa Ethiopia 150201
2 Swiss Federal Institute of Technology (ETH) Zurich Switzerland 9092

Sponsors and Collaborators

  • Swiss Federal Institute of Technology
  • HarvestPlus
  • Addis Ababa University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Prof. Michael B. Zimmermann, Professor and Head of Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT03353662
Other Study ID Numbers:
  • Ethiopia_SRMNS
First Posted:
Nov 27, 2017
Last Update Posted:
Jun 21, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Michael B. Zimmermann, Professor and Head of Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich, Swiss Federal Institute of Technology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2018