Iron Absorption From Rice Fortified With Ferric Pyrophosphate
Primary Purpose
Iron Deficiency, Anemia, Iron Deficiency Anemia
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Administration of rice fortified with regular FePP
Administration of rice fortified with regular FePP with citrate added during extrusion
Administration of rice fortified with regular FePP and citrate added at consumption
Administration of rice fortified with ferrous sulphate
Sponsored by
About this trial
This is an interventional prevention trial for Iron Deficiency
Eligibility Criteria
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)
Sites / Locations
- Human Nutrition Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Regular FePP
Regular FePP with citrate added during extrusion
Regular FePP with citrated added at consumption
Ferrous sulphate
Arm Description
Rice (50g dry weight) fortified with 4mg regular FePP
Rice (50g dry weight) fortified with 4mg regular FePP and citrate added during the extrusion process
Rice (50g dry weight) fortified with 4mg regular FePP and citrate shortly added before consumption
Rice (50g dry weight) fortified with 4mg ferrous sulphate
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02176759
First Posted
June 25, 2014
Last Updated
December 23, 2014
Sponsor
Swiss Federal Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT02176759
Brief Title
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Anemia, Iron Deficiency Anemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular FePP
Arm Type
Experimental
Arm Description
Rice (50g dry weight) fortified with 4mg regular FePP
Arm Title
Regular FePP with citrate added during extrusion
Arm Type
Experimental
Arm Description
Rice (50g dry weight) fortified with 4mg regular FePP and citrate added during the extrusion process
Arm Title
Regular FePP with citrated added at consumption
Arm Type
Experimental
Arm Description
Rice (50g dry weight) fortified with 4mg regular FePP and citrate shortly added before consumption
Arm Title
Ferrous sulphate
Arm Type
Active Comparator
Arm Description
Rice (50g dry weight) fortified with 4mg ferrous sulphate
Intervention Type
Other
Intervention Name(s)
Administration of rice fortified with regular FePP
Intervention Type
Other
Intervention Name(s)
Administration of rice fortified with regular FePP with citrate added during extrusion
Intervention Type
Other
Intervention Name(s)
Administration of rice fortified with regular FePP and citrate added at consumption
Intervention Type
Other
Intervention Name(s)
Administration of rice fortified with ferrous sulphate
Primary Outcome Measure Information:
Title
Change from baseline in the isotopic ratio of iron in blood at week 2
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
baseline, 2 weeks
Title
Change from week 2 in the isotopic ratio of iron in blood at week 4
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
2 weeks, 4 weeks
Title
Change from week 4 in the isotopic ratio of iron in blood at week 6
Description
The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.
Time Frame
4 weeks, 6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Human Nutrition Laboratory
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
29046406
Citation
Hackl L, Speich C, Zeder C, Sanchez-Ferrer A, Adelmann H, de Pee S, Tay F, Zimmermann MB, Moretti D. Cold Extrusion but Not Coating Affects Iron Bioavailability from Fortified Rice in Young Women and Is Associated with Modifications in Starch Microstructure and Mineral Retention during Cooking. J Nutr. 2017 Dec;147(12):2319-2325. doi: 10.3945/jn.117.259085. Epub 2017 Oct 18.
Results Reference
derived
PubMed Identifier
27053382
Citation
Hackl L, Cercamondi CI, Zeder C, Wild D, Adelmann H, Zimmermann MB, Moretti D. Cofortification of ferric pyrophosphate and citric acid/trisodium citrate into extruded rice grains doubles iron bioavailability through in situ generation of soluble ferric pyrophosphate citrate complexes. Am J Clin Nutr. 2016 May;103(5):1252-9. doi: 10.3945/ajcn.115.128173. Epub 2016 Apr 6.
Results Reference
derived
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Iron Absorption From Rice Fortified With Ferric Pyrophosphate
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