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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02255942
Acronym
Rice_FeZn
Enrollment
20
Registered
2014-10-03
Start date
2015-04-30
Completion date
2015-07-31
Last updated
2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Deficiency

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.

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.

Interventions

Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)

OTHERFerrous sulfate

Rice fortified with Ferrous Sulfate (ZnSO4)

OTHERFerric Pyrophosphate and Zinc Sulfate

Rice fortified with Ferric Pyrophosphate and Zinc Sulfate

Rice fortified with Ferric Pyrophosphate

Sponsors

PATH
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in the isotopic ratio of iron in blood at week 2baseline, 2 weeksThe 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 42 weeks, 4 weeksThe 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 64 weeks, 6 weeksThe change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Secondary

MeasureTime frameDescription
Haemoglobinbaseline, 16th, 30th and 44th day14 or 15 days after each meal administration and at baseline
Plasma Ferritinbaseline, 16th, 30th and 44th day14 or 15 days after each meal administration and at baseline
C reactive proteinbaseline, 16th, 30th and 44th day14 or 15 days after each meal administration and at baseline

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026