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Trial record 76 of 380 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT02255942
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : April 14, 2016
Sponsor:
Collaborator:
PATH
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, 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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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




Primary Outcome Measures :
  1. Change from baseline in the isotopic ratio of iron in blood at week 2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: baseline, 16th, 30th and 44th day ]
    14 or 15 days after each meal administration and at baseline

  2. Plasma Ferritin [ Time Frame: baseline, 16th, 30th and 44th day ]
    14 or 15 days after each meal administration and at baseline

  3. C reactive protein [ Time Frame: baseline, 16th, 30th and 44th day ]
    14 or 15 days after each meal administration and at baseline



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255942


Locations
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Switzerland
ETH Zürich, Laboratory of Human Nutrition
Zürich, ZH, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
PATH
Investigators
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Principal Investigator: Michael Zimmermann, Prof.Dr., MD University of Zurich

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Michael B. Zimmermann, Prof.Dr., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT02255942     History of Changes
Other Study ID Numbers: Rice-FePP-Zn
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: September 2015
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Zinc
Zinc Sulfate
Zinc Oxide
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents
Sunscreening Agents
Radiation-Protective Agents
Protective Agents