NCT03355287

Brief Summary

To assess the impact of soil iron intake from teff flour on iron status in infants in Debre Zeit, Ethiopia.

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
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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
15 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

November 13, 2017

Last Update Submit

September 3, 2018

Conditions

Iron-deficiencyIron Deficiency AnemiaAluminium Intoxication

Outcome Measures

Primary Outcomes (5)

  • Change in Haemoglobin

    Iron status

    Three collection points - First collection point at screening, second collection point at mid point (3.5 months after start of intervention) and third collection point at the end point ( end of the 7 months of the intervention)

  • Change in Ferritin

    Iron status

    Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )

  • Change in Soluble Transferrin Receptor (sTfR)

    Iron status

    Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )

  • Change in C-Reactive Protein (CRP)

    Inflammation

    Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )

  • Change in Alpha 1-Acid Glycoprotein (AGP)

    Inflammation

    Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )

Secondary Outcomes (9)

  • Change in Aluminium (Al) levels

    Two collection points - First collection point at screening, second collection point at the end of the study ( 7 months after the intervention start )

  • Change in Aluminium (Al) levels

    Three collection points - First collection point at the first day of the study, Second collection point during mid point ( 3.5 months after start of the intervention, and third collection point at the end of the intervention ( end of 7th month)

  • Change in Anthropometric measurements

    Three collection points - First collection point during screening, Second collection point during mid point ( 3.5 months after start of the intervention, and third collection point at the end of the intervention ( end of 7th month)

  • Change in Anthropometric measurements

    Three collection points - First collection point during screening, Second collection point during mid point ( 3.5 months after start of the intervention, and third collection point at the end of the intervention ( end of 7th month)

  • Teff flour

    Through study completion, an average of 7 months

  • +4 more secondary outcomes

Study Arms (3)

Traditionally Threshed Teff (TTT)

PLACEBO COMPARATOR

The control group will consume injera based on teff threshed under the hooves of cattle. We plan to have a certain number of teff flour suppliers, where the teff is traditionally threshed and contains at least 50 mg Fe per 100 g flour.

Other: Traditionally Threshed Teff (TTT)

Lab Threshed Teff (LTT)

EXPERIMENTAL

The intervention group will consume injera based on teff flour that has been lab threshed using a modern teff threshing machine.

Other: Lab Threshed Teff (LTT)

Fortified Lab Threshed Teff (FTT)

ACTIVE COMPARATOR

This arm will be the positive control group consuming Ferrous Sulphate drops ( with injera that consist of lab-threshed teff. The Fe drops have to be consumed with the meal and will provide an additional 6 mg of Ferrous sulfate to the diet of the children.

Other: Fortified Lab Threshed Teff (FTT)

Interventions

Traditionally Threshed Teff (TTT)OTHER

The intervention will take place for 7 months in Debre Zeit where the the arm will be fed injera based on teff that are threshed traditionally

Traditionally Threshed Teff (TTT)
Lab Threshed Teff (LTT)OTHER

The intervention will take place for 7 months in Debre Zeit where this arm will be fed injera from teff that is threshed using a modern thresher.

Lab Threshed Teff (LTT)
Fortified Lab Threshed Teff (FTT)OTHER

The intervention will take place for 7 months in Debre Zeit where this arm will be fed injera from teff that is threshed using a modern thresher. In addition, they will receive Ferrous sulfate drops

Fortified Lab Threshed Teff (FTT)

Eligibility Criteria

Age18 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months of age (at screening)
  • The child is able to eat at least two injera meals per day
  • 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 deficient in Hb (\<70g/L)
  • Severe underweight (weight for age Z score \< -3),
  • Severe wasting (weight for height Z score \< -3)
  • 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
  • Not planning long-term residence in study site

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

Zurich, 8092, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Michael Zimmermann, Dr. PhD

    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

+41 44 632 86 34colin.cercamondi@hest.ethz.ch

Amrutha Anandaraman, MSc

CONTACT

+41 44 832 93 41amrutha.anandaraman@hest.ethz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.Prof.

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 28, 2017

Study Start

November 1, 2018

Primary Completion

June 1, 2019

Study Completion

August 1, 2019

Last Updated

September 5, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)ET(1)