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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Iron Deficiency

Intervention / Treatment
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* Other: Ferric Pyrophosphate and Zinc Oxide
* Other: Ferrous sulfate
* Other: Ferric Pyrophosphate and Zinc Sulfate
* Other: Ferric Pyrophosphate


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron fortified rice<br>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<br>* Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)<br>Other: Ferrous sulfate<br>* Rice fortified with Ferrous Sulfate (ZnSO4)<br>Other: Ferric Pyrophosphate and Zinc Sulfate<br>* Rice fortified with Ferric Pyrophosphate and Zinc Sulfate<br>Other: Ferric Pyrophosphate<br>* Rice fortified with Ferric Pyrophosphate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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