ClinicalTrials.gg
Status unknownNCT03353662Updated Jun 21, 2018

Sub Regional Micronutrient Survey in Ethiopia

An observational study in Iron-deficiency, Vitamin A Deficiency and Zinc Deficiency, sponsored by Swiss Federal Institute of Technology. Status unknown at 2 sites in 2 countries. Open to participants aged 5 Months to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-21.

Sponsored by Swiss Federal Institute of Technology · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
1,200
Ages
5 Months to 49 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 36 studies in Anemia, Iron-Deficiency by Swiss Federal Institute of Technology — 1 open to participants now, 1 under way, none of them phase 3. Anemia, Iron-Deficiency · Swiss Federal Institute of Technology.

Started
2018
with 8 others
Observational
3 of 36
none open now
Registered
10th of 36
by date

Among the 36 studies in Anemia, Iron-Deficiency by Swiss Federal Institute of Technology, this one is one of 9 that started in 2018, is one of 3 observational ones, and was the 10th registered.

Anemia, Iron-Deficiency

600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.

Browse Anemia, Iron-Deficiency studies →

Open to participants now

1 of the 36 studies in Anemia, Iron-Deficiency by Swiss Federal Institute of Technology is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Who these studies take

Of the 54 Anemia, Iron-Deficiency studies recruiting now, 19 (35%) set no upper age limit and 31 (57%) stop at 75 or younger; 15 take children under 18; 17 take healthy volunteers.

This study: 5 Months to 49 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 36 studies in Anemia, Iron-Deficiency by Swiss Federal Institute of Technology, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Iron-deficiency
  • Vitamin A Deficiency
  • Zinc Deficiency

Keywords

  • bio fortification
04

Who can participate

Ages eligible
5 Months to 49 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 5-59 months of age for children
  • 15-49 years for women of reproductive age.
  • The form has been read and signed by the caregiver (or has been read out to the caregiver in case of illiteracy)

Exclusion criteria

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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
1,200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Interventions

  • OtherWomen 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.

  • OtherChildren 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.

  • OtherWomen 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.

  • OtherChildren 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.

  • OtherWomen 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.

  • OtherChildren 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.

06

What researchers measure

Primary outcomes

  1. Prevalence of Anaemia

    Prevalence of iron deficiency with or without anemia

    Time frame: March 2018

  2. Prevalence of Zinc deficiency

    Based on plasma Zinc concentration

    Time frame: March 2018

  3. Prevalence of Vitamin A deficiency

    Measuring Vitamin A biomarkers

    Time frame: March 2018

Secondary outcomes

  1. Inflammation biomarkers

    C reactive protein (CRP)

    Time frame: March 2018

  2. Anthropometric measurement - Height

    height in cm

    Time frame: March 2018

  3. Anthropometric measurement - Weight

    weight in Kg

    Time frame: March 2018

  4. Inflammation Biomarker

    Alpha 1-acid glycoprotein (AGP)

    Time frame: March 2018

07

Study locations

2 sites
  • Center for Food Science and Nutrition, Addis Ababa University
    Addis Ababa, 150201, Ethiopia
  • Swiss Federal Institute of Technology (ETH)
    Zurich, 9092, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2018; primary completion for Dec 2018, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 13, 2017
First posted
Nov 27, 2017
StartEst.
Sep 2018
Primary completionEst.
Dec 2018
CompletionEst.
Jun 2019
Last update
Jun 21, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03353662
Collaborators
HarvestPlus, Addis Ababa University
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) — Principal investigator
First posted
Nov 27, 2017
Start date
Sep 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Jun 2019 (estimated)
Last update
Jun 21, 2018

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion