NCT03353662

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 21, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

November 13, 2017

Last Update Submit

June 20, 2018

Conditions

Iron-deficiencyVitamin A DeficiencyZinc Deficiency

Keywords

bio fortification

Outcome Measures

Primary Outcomes (3)

  • Prevalence of Anaemia

    Prevalence of iron deficiency with or without anemia

    March 2018

  • Prevalence of Zinc deficiency

    Based on plasma Zinc concentration

    March 2018

  • Prevalence of Vitamin A deficiency

    Measuring Vitamin A biomarkers

    March 2018

Secondary Outcomes (4)

  • Inflammation biomarkers

    March 2018

  • Anthropometric measurement - Height

    March 2018

  • Anthropometric measurement - Weight

    March 2018

  • Inflammation Biomarker

    March 2018

Study Arms (6)

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

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.

Women of Gamo Gofa
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.

Children of Gamo Gofa
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.

Women of West Gojjam
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.

Children of West Gojjam
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.

Women of Kamashi
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.

Children of Kamashi

Eligibility Criteria

Age5 Months - 49 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFor the Children, both male and female are included. For adults, only women between ages of 15 and 49 are included.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • months of age for children
  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Food Science and Nutrition, Addis Ababa University

Addis Ababa, 150201, Ethiopia

Location

Swiss Federal Institute of Technology (ETH)

Zurich, 9092, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Plasma will be retained, however, will only be used to measure micronutrient status

MeSH Terms

Conditions

Anemia, Iron-DeficiencyVitamin A Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Cercamondi, PhD

CONTACT

0041 44632 86 34colin.cercamondi@hest.ethz.ch

Amrutha Anandaraman, MSc

CONTACT

0041 44632 93 41amrutha.anandaraman@hest.ethz.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 27, 2017

Study Start

September 1, 2018

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

June 21, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)CH(1)