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

Iron Deficiency Clinical Trial

— Rice_FeZn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02255942
• Other study ID #: Rice-FePP-Zn
• Status: Completed
• Phase: N/A
• First received: September 19, 2014
• Last updated: April 13, 2016
• Start date: April 2015
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron Deficiency

Intervention

Other:
• Ferric Pyrophosphate and Zinc Oxide
Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)
• Ferrous sulfate
Rice fortified with Ferrous Sulfate (ZnSO4)
• Ferric Pyrophosphate and Zinc Sulfate
Rice fortified with Ferric Pyrophosphate and Zinc Sulfate
• Ferric Pyrophosphate
Rice fortified with Ferric Pyrophosphate

Locations

Country	Name	City	State
Switzerland	ETH Zürich, Laboratory of Human Nutrition	Zürich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	PATH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Haemoglobin	14 or 15 days after each meal administration and at baseline	baseline, 16th, 30th and 44th day	No
Secondary	Plasma Ferritin	14 or 15 days after each meal administration and at baseline	baseline, 16th, 30th and 44th day	No
Secondary	C reactive protein	14 or 15 days after each meal administration and at baseline	baseline, 16th, 30th and 44th day	No