Iron Absorption From Rice Fortified With Ferric Pyrophosphate

December 23, 2014 updated by: Swiss Federal Institute of Technology

Ferric pyrophosphate (FePP) is a water-insoluble, food grade iron compound used to fortify rice, infant cereals and chocolate-drink powders as it causes no organoleptic changes to the food vehicle. However, it is only of low absorption in man. Therefore, strategies to enhance the bioavailability of FePP, such as adding citrate or decreasing the particle size of FePP need to be investigated. The primary objectives of the present study are: 1) to test whether the presence of citrate in iron fortified rice with FePP results in higher iron bioavailability, and 2) to test whether the presence of citrate in the rice grain during the extrusion and cooking process results in higher iron bioavailability compared with iron-fortified rice where citrate has been added shortly before consumption. As a secondary objective the investigators will compare the absorption from different FePP combinations with a reference meal fortified with ferrous sulphate. The investigator hypothesize that the addition of citrate enhances iron absorption and that the positive effect is greater when the citrate is added during the extrusion.

The investigator will conduct an iron absorption study in 20 women, 18 to 45 years old to evaluate the iron bioavailability from extruded rice fortified with 1) regular FePP, 2) regular FePP and citrate (both extruded into the rice kernels), 3) regular FePP and citrate added at the time of consumption, and 4) from normal rice fortified with ferrous sulphate at the time of consumption. Iron absorption will be measured as erythrocyte incorporation of stable iron isotopes at least 14 days after the administration of the isotopically labelled test meals. The iron absorption from the different meals within the same participant will be compared by repeated-measures ANOVA followed by a Bonferroni corrected pairwise comparison.

The present study will provide important data where iron bioavailability from rice is accurately and directly measured using stable isotopic labels as absorption tracers. This direct data can be used to base decisions on the level of fortification, can potentially reduce costs and optimize iron delivery to the targeted population in iron fortification programs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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
      • Zurich, Switzerland, 8092
        • Human Nutrition Laboratory

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

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female, 18 to 45 years old
  • Normal body Mass Index (18.5 - 25 kg/m2)
  • Body weight < 65 kg
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy (assessed by a pregnancy test)
  • Lactating
  • Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, hepatitis, hypertension, cancer or cardiovascular diseases (according to the participants own statement)
  • Continuous/long-term use of medication during the whole study (except for contraceptives)
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st meal administration
  • Blood transfusion, blood donation or significant blood loss (accident, surgery) over the past 4 months
  • Earlier participation in a study using Fe stable isotopes or participation in any clinical study within the last 30 days
  • Participant who cannot be expected to comply with study protocol (e.g. not available on certain study appointments)

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Regular FePP
Rice (50g dry weight) fortified with 4mg regular FePP
Other: Administration of rice fortified with regular FePP
EXPERIMENTAL: Regular FePP with citrate added during extrusion
Rice (50g dry weight) fortified with 4mg regular FePP and citrate added during the extrusion process
Other: Administration of rice fortified with regular FePP with citrate added during extrusion
EXPERIMENTAL: Regular FePP with citrated added at consumption
Rice (50g dry weight) fortified with 4mg regular FePP and citrate shortly added before consumption
Other: Administration of rice fortified with regular FePP and citrate added at consumption
ACTIVE_COMPARATOR: Ferrous sulphate
Rice (50g dry weight) fortified with 4mg ferrous sulphate
Other: Administration of rice fortified with ferrous sulphate

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

Collaborators and Investigators

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

Sponsor

Swiss Federal Institute of Technology

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

September 1, 2014

Primary Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 26, 2014

First Posted (ESTIMATE)

June 27, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2014

Last Update Submitted That Met QC Criteria

December 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rice_SFePP

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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