NCT02176759

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

December 24, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

June 25, 2014

Last Update Submit

December 23, 2014

Conditions

Iron DeficiencyAnemiaIron Deficiency Anemia

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

Study Arms (4)

Regular FePP

EXPERIMENTAL

Rice (50g dry weight) fortified with 4mg regular FePP

Other: Administration of rice fortified with regular FePP

Regular FePP with citrate added during extrusion

EXPERIMENTAL

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

Regular FePP with citrated added at consumption

EXPERIMENTAL

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

Ferrous sulphate

ACTIVE COMPARATOR

Rice (50g dry weight) fortified with 4mg ferrous sulphate

Other: Administration of rice fortified with ferrous sulphate

Interventions

Administration of rice fortified with regular FePPOTHER
Regular FePP
Administration of rice fortified with regular FePP with citrate added during extrusionOTHER
Regular FePP with citrate added during extrusion
Administration of rice fortified with regular FePP and citrate added at consumptionOTHER
Regular FePP with citrated added at consumption
Administration of rice fortified with ferrous sulphateOTHER
Ferrous sulphate

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Laboratory

Zurich, Canton of Zurich, 8092, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 29046406DERIVED

  • 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.

    PMID: 27053382DERIVED

MeSH Terms

Conditions

Iron DeficienciesAnemiaAnemia, Iron-Deficiency

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHematologic DiseasesHemic and Lymphatic DiseasesAnemia, Hypochromic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 27, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Last Updated

December 24, 2014

Record last verified: 2014-06

Locations

CH(1)