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

• Sponsor: Swiss Federal Institute of Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02255942
• Collaborator: PATH (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 6.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency	Other: Ferric Pyrophosphate and Zinc Oxide; Other: Ferrous sulfate; Other: Ferric Pyrophosphate and Zinc Sulfate; Other: Ferric Pyrophosphate	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: The Effect of Zinc on Iron Bioavailability From Fortified Extruded Rice Fortified With Ferric Pyrophosphate
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iron fortified rice 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; Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO); Other: Ferrous sulfate; Rice fortified with Ferrous Sulfate (ZnSO4); Other: Ferric Pyrophosphate and Zinc Sulfate; Rice fortified with Ferric Pyrophosphate and Zinc Sulfate; Other: Ferric Pyrophosphate; Rice fortified with Ferric Pyrophosphate

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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

1. Haemoglobin [baseline, 16th, 30th and 44th day]

   14 or 15 days after each meal administration and at baseline

2. Plasma Ferritin [baseline, 16th, 30th and 44th day]

   14 or 15 days after each meal administration and at baseline

3. C reactive protein [baseline, 16th, 30th and 44th day]

   14 or 15 days after each meal administration and at baseline

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ETH Zürich, Laboratory of Human Nutrition	Zürich	ZH	Switzerland	8092

Sponsors and Collaborators

• Swiss Federal Institute of Technology
• PATH

Investigators

• Principal Investigator: Michael Zimmermann, Prof.Dr., MD, ETH Zürich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Michael B. Zimmermann, Prof.Dr., Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT02255942
• Other Study ID Numbers: Rice-FePP-Zn
• First Posted: Oct 3, 2014
• Last Update Posted: Apr 14, 2016
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Anemia, Iron-Deficiency; Zinc; Iron; Zinc Sulfate; Zinc Oxide

Study Results

No Results Posted as of Apr 14, 2016