The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate (Rice_FeZn)

April 13, 2016 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ferric Pyrophosphate (FePP) is a water-insoluble, food grade, iron compound widely used to fortify rice and other foods as it causes no organoleptic changes to the food vehicles. However, it is only of low absorption in man and its absorption can be influenced by a variety of compounds. The effect of co-fortification of rice with ZnO respectively ZnSO4 on iron bioavailability in extruded rice fortified with FePP has never been investigated.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zürich, ZH, Switzerland, 8092
        • ETH Zurich, Laboratory of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Iron fortified rice
Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
Other: Ferric Pyrophosphate and Zinc Oxide
Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)
Other: Ferrous sulfate
Rice fortified with Ferrous Sulfate (ZnSO4)
Other: Ferric Pyrophosphate and Zinc Sulfate
Rice fortified with Ferric Pyrophosphate and Zinc Sulfate
Other: Ferric Pyrophosphate
Rice fortified with Ferric Pyrophosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the isotopic ratio of iron in blood at week 2
Time Frame: baseline, 2 weeks
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
Time Frame: 2 weeks, 4 weeks
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
Time Frame: 4 weeks, 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Haemoglobin
Time Frame: baseline, 16th, 30th and 44th day
14 or 15 days after each meal administration and at baseline
baseline, 16th, 30th and 44th day
Plasma Ferritin
Time Frame: baseline, 16th, 30th and 44th day
14 or 15 days after each meal administration and at baseline
baseline, 16th, 30th and 44th day
C reactive protein
Time Frame: baseline, 16th, 30th and 44th day
14 or 15 days after each meal administration and at baseline
baseline, 16th, 30th and 44th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

PATH

Investigators

  • Principal Investigator: Michael Zimmermann, Prof.Dr., MD, ETH Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

April 14, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rice-FePP-Zn

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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