Iron-deficiencyNCT03353662
Sub Regional Micronutrient Survey in Ethiopia
An observational study of Iron-deficiency and Vitamin A Deficiency, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
Trial summary
To conduct a sub-regional micronutrient survey (SRMNS) assessing the prevalence of vitamin A, Zn, and Fe status in the country Read more about this study
- Who is it for?
- Ages 5 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency, Vitamin A Deficiency, Zinc Deficiency
- What is being tested?
- Women of Gamo Gofa, Children of Gamo Gofa and Women of West Gojjam
- How many people
- 1,200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2018to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Ethiopia1 site
Center for Food Science and Nutrition, Addis Ababa University
Addis Ababa, 150201
Kaleab Baye, PhD, +251.911.890489, kaleabbaye@gmail.com
Switzerland1 site
Swiss Federal Institute of Technology (ETH)
Zurich, 9092
Michael B Zimmermann, Prof. Dr., 0041 44632 86 57, michael.zimmermann@hest.ethz.ch
Amrutha Anandaraman, MSc, 0041 44632 93 41, amrutha.anandaraman@hest.ethz.ch
About this study
Official title: The Assessment of Sub-Regional Micronutrient Deficiencies in Ethiopia to Target Bio Fortification.
To conduct a sub-regional micronutrient survey (SRMNS) assessing the prevalence of vitamin A, Zn, and Fe status in the country
Read the 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.
- Conditions
- Iron-deficiency, Vitamin A Deficiency, Zinc Deficiency
- Being tested
- Women of Gamo Gofa, Children of Gamo Gofa, Women of West Gojjam, Children of West Gojjam, Women of Kamashi
- Keywords
- bio fortification
- Medical subject headings
- Anemia, Iron-Deficiency, Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women of Gamo GofaOther
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 GofaOther
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 GojjamOther
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 GojjamOther
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 KamashiOther
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 KamashiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Women of Gamo Gofa | |
| 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 Receives: Other: Children of Gamo Gofa | |
| 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 Receives: Other: Women of West Gojjam | |
| 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 Receives: Other: Children of West Gojjam | |
| Women of Kamashi | The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Kamashi between 15-49 years Receives: Other: Women of Kamashi | |
| Children of Kamashi | The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Kamashi between 6 - 59 months Receives: Other: Children of Kamashi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Anaemia
Prevalence of iron deficiency with or without anemia
Measured: March 2018
Prevalence of Zinc deficiency
Based on plasma Zinc concentration
Measured: March 2018
Prevalence of Vitamin A deficiency
Measuring Vitamin A biomarkers
Measured: March 2018
Secondary outcomes (4)
Inflammation biomarkers
C reactive protein (CRP)
Measured: March 2018
Anthropometric measurement - Height
height in cm
Measured: March 2018
Anthropometric measurement - Weight
weight in Kg
Measured: March 2018
Inflammation Biomarker
Alpha 1-acid glycoprotein (AGP)
Measured: March 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study startSep 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- HarvestPlus, Addis Ababa University
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael Zimmermann, PhD, Principal investigator, Professor and Head, Human Nutrition, Swiss Federal Institute of Technology (ETH) Zurich, SwitzerlandKaleab Baye, PhD, Principal investigator, Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353662
- Sponsor's protocol ID
- Ethiopia_SRMNS
- Status last verified
- Jun 2018
- First submitted
- 13 Nov 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Sub-Regional Micronutrient Deficiencies in Ethiopia to Target Bio Fortification.
- ClinicalTrials.gov ID
- NCT03353662
- Acronym / sponsor ID
- Ethiopia_SRMNS
- Conditions
- Iron-deficiency, Vitamin A Deficiency, Zinc Deficiency
- Keywords
- bio fortification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- HarvestPlus, Addis Ababa University
- Study start
- Sep 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Women of Gamo Gofa | – | Other: Women of Gamo GofaThe prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Gamo Gofa between 15-49 years |
| Children of Gamo Gofa | – | Other: Children of Gamo GofaThe prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Gamo Gofa between 6 - 59 months |
| Women of West Gojjam | – | Other: Women of West GojjamThe prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of West Gojjam between 15-49 years |
| Children of West Gojjam | – | Other: Children of West GojjamThe prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of West Gojjam between 6 - 59 months |
| Women of Kamashi | – | Other: Women of KamashiThe prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Kamashi between 15-49 years |
| Children of Kamashi | – | Other: Children of KamashiThe prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Kamashi between 6 - 59 months |
Who may qualify
- Ages
- 5 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women of Gamo GofaThe 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. | Other | Women of Gamo Gofa |
| Children of Gamo GofaThe 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. | Other | Children of Gamo Gofa |
| Women of West GojjamThe 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. | Other | Women of West Gojjam |
| Children of West GojjamThe 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. | Other | Children of West Gojjam |
| Women of KamashiThe 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. | Other | Women of Kamashi |
| Children of KamashiThe 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. | Other | Children of Kamashi |
Primary outcome
Prevalence of Anaemia
Time frame: March 2018
Prevalence of iron deficiency with or without anemia
Prevalence of Zinc deficiency
Time frame: March 2018
Based on plasma Zinc concentration
Prevalence of Vitamin A deficiency
Time frame: March 2018
Measuring Vitamin A biomarkers
4 secondary outcomes
Inflammation biomarkers
Time frame: March 2018
Anthropometric measurement - Height
Time frame: March 2018
Anthropometric measurement - Weight
Time frame: March 2018
Inflammation Biomarker
Time frame: March 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: No
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The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
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Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zimmermann, PhD principal investigator
Professor and Head, Human Nutrition, Swiss Federal Institute of Technology (ETH) Zurich, Switzerland
Kaleab Baye, PhD principal investigator
Assistant Professor and Head, Center for Food Science and Nutrition, Addis Ababa Univeristy, Ethiopia
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency and Vitamin A Deficiency, run by Swiss Federal Institute of Technology at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ethiopia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colin Cercamondi, PhD (0041 44632 86 34, colin.cercamondi@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Anaemia (time frame: March 2018). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.