The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate
Rice_FeZn
1 other identifier
interventional
20
1 country
1
Brief Summary
Investigation of Iron Bioavailability from extruded rice grains fortified with Ferric Pyrophosphate alone or in combination with different Zinc Compounds; Ferrous Sulfate serves as a Reference.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2015
Shorter than P25 for not_applicable
1 active site
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
September 19, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 14, 2016
September 1, 2015
2 months
September 19, 2014
April 13, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Change from baseline in the isotopic ratio of iron in blood at week 2
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
baseline, 2 weeks
Change from week 2 in the isotopic ratio of iron in blood at week 4
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
2 weeks, 4 weeks
Change from week 4 in the isotopic ratio of iron in blood at week 6
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
4 weeks, 6 weeks
Secondary Outcomes (3)
Haemoglobin
baseline, 16th, 30th and 44th day
Plasma Ferritin
baseline, 16th, 30th and 44th day
C reactive protein
baseline, 16th, 30th and 44th day
Study Arms (1)
Iron fortified rice
EXPERIMENTALAdministration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
Interventions
Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)
Rice fortified with Ferric Pyrophosphate and Zinc Sulfate
Eligibility Criteria
You may qualify if:
- Female
- Serum Ferritin Level \< 15 µg/L
- Body weight \<65 kg
- Signed informed consent 4. Body Mass Index in the range of 18.5 to 25
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss Federal Institute of Technologylead
- PATHcollaborator
Study Sites (1)
ETH Zürich, Laboratory of Human Nutrition
Zurich, Canton of Zurich, 8092, Switzerland
Related Publications (1)
Hackl L, Zimmermann MB, Zeder C, Parker M, Johns PW, Hurrell RF, Moretti D. Iron Bioavailability from Ferric Pyrophosphate in Extruded Rice Cofortified with Zinc Sulfate Is Greater than When Cofortified with Zinc Oxide in a Human Stable Isotope Study. J Nutr. 2017 Mar;147(3):377-383. doi: 10.3945/jn.116.241778. Epub 2017 Feb 1.
PMID: 28148685DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Zimmermann, Prof.Dr., MD
ETH Zürich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.Dr.
Study Record Dates
First Submitted
September 19, 2014
First Posted
October 3, 2014
Study Start
April 1, 2015
Primary Completion
June 1, 2015
Study Completion
July 1, 2015
Last Updated
April 14, 2016
Record last verified: 2015-09