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Zinc Absorption From Biofortified Rice

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ClinicalTrials.gov Identifier: NCT01633450
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : June 7, 2013
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Study Description
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Brief Summary:
One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.

Condition or disease Intervention/treatment Phase
Healthy Other: Zinc biofortified rice Other: Rice extrinsically fortified with zinc Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study
Study Start Date : June 2012
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012
Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Zinc biofortified rice Other: Zinc biofortified rice
1.12 mg zinc per meal
Active Comparator: Rice extrinsically fortified with zinc Other: Rice extrinsically fortified with zinc
1.12 mg zinc per meal


Outcome Measures
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Primary Outcome Measures :
  1. Fractional absorption of zinc [ Time Frame: 33 days ]
    Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.


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

Inclusion Criteria:

  • Male or female of 18 to 45 years old
  • Body Mass Index in the range of 19 to 25
  • No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

  • Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
  • Long-term medication during the whole study (except for contraceptives)
  • Pregnancy
  • Lactation
  • Intention to become pregnant during the course of the study
  • Lack of safe contraception
  • Consumption of mineral and vitamin supplements within 2 weeks prior to 1st - Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01633450


Locations
Switzerland
ETH Zurich
Zurich, Switzerland
Sponsors and Collaborators
Swiss Federal Institute of Technology
University of Zurich
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01633450     History of Changes
Other Study ID Numbers: HNL/CTC12-Reis
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs