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

Not Applicable

Completed

• Conditions: Iron Deficiency
• Interventions: Other: Ferric Pyrophosphate and Zinc Oxide; Other: Ferrous sulfate; Other: Ferric Pyrophosphate and Zinc Sulfate; Other: Ferric Pyrophosphate

• Registration Number: NCT02255942
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study First Submitted: 2014-09-19
• Study First Submitted QC: 2014-09-30
• Study First Posted: 2014-10-03
• Study Start: 2015-04
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iron fortified rice	Ferric Pyrophosphate	Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
Iron fortified rice	Ferrous sulfate	Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
Iron fortified rice	Ferric Pyrophosphate and Zinc Sulfate	Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.
Iron fortified rice	Ferric Pyrophosphate and Zinc Oxide	Administration of iron fortified rice to all subjects; subjects will act as their own controls and each subject will receive all foreseen treatments/interventions.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the isotopic ratio of iron in blood at week 2	baseline, 2 weeks	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	2 weeks, 4 weeks	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	4 weeks, 6 weeks	The change in the isotopic ratio of iron will be measured after the administration of test meal including iron isotopes.

Secondary Outcome Measures

Name	Time	Method
Haemoglobin	baseline, 16th, 30th and 44th day	14 or 15 days after each meal administration and at baseline
C reactive protein	baseline, 16th, 30th and 44th day	14 or 15 days after each meal administration and at baseline
Plasma Ferritin	baseline, 16th, 30th and 44th day	14 or 15 days after each meal administration and at baseline

Trial Locations

Locations (1)

ETH Zürich, Laboratory of Human Nutrition; 🇨🇭 Zürich, ZH, Switzerland