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Sub Regional Micronutrient Survey in Ethiopia

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ClinicalTrials.gov Identifier: NCT03353662
Recruitment Status : Not yet recruiting
First Posted : November 27, 2017
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
HarvestPlus
Addis Ababa University
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

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
Iron-deficiency Vitamin A Deficiency Zinc Deficiency 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.


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Study Type : Observational
Estimated 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.
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Group/Cohort 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.




Primary Outcome Measures :
  1. Prevalence of Anaemia [ Time Frame: March 2018 ]
    Prevalence of iron deficiency with or without anemia

  2. Prevalence of Zinc deficiency [ Time Frame: March 2018 ]
    Based on plasma Zinc concentration

  3. Prevalence of Vitamin A deficiency [ Time Frame: March 2018 ]
    Measuring Vitamin A biomarkers


Secondary Outcome Measures :
  1. Inflammation biomarkers [ Time Frame: March 2018 ]
    C reactive protein (CRP)

  2. Anthropometric measurement - Height [ Time Frame: March 2018 ]
    height in cm

  3. Anthropometric measurement - Weight [ Time Frame: March 2018 ]
    weight in Kg

  4. Inflammation Biomarker [ Time Frame: March 2018 ]
    Alpha 1-acid glycoprotein (AGP)


Biospecimen Retention:   Samples Without DNA
Blood Plasma will be retained, however, will only be used to measure micronutrient status


Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 49 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   For the Children, both male and female are included. For adults, only women between ages of 15 and 49 are included.
Accepts Healthy Volunteers:   Yes
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353662


Contacts
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Contact: Colin Cercamondi, PhD 0041 44632 86 34 colin.cercamondi@hest.ethz.ch
Contact: Amrutha Anandaraman, MSc 0041 44632 93 41 amrutha.anandaraman@hest.ethz.ch

Locations
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Ethiopia
Center for Food Science and Nutrition, Addis Ababa University Not yet recruiting
Addis Ababa, Ethiopia, 150201
Contact: Kaleab Baye, PhD    +251.911.890489    kaleabbaye@gmail.com   
Switzerland
Swiss Federal Institute of Technology (ETH) Not yet recruiting
Zurich, Switzerland, 9092
Contact: Michael B Zimmermann, Prof. Dr.    0041 44632 86 57    michael.zimmermann@hest.ethz.ch   
Contact: Amrutha Anandaraman, MSc    0041 44632 93 41    amrutha.anandaraman@hest.ethz.ch   
Sponsors and Collaborators
Swiss Federal Institute of Technology
HarvestPlus
Addis Ababa University
Investigators
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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

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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     History of Changes
Other Study ID Numbers: Ethiopia_SRMNS
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Swiss Federal Institute of Technology:
bio fortification

Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Vitamin A Deficiency
Night Blindness
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin A
Micronutrients
Retinol palmitate
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents