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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

Tracking Information
First Submitted Date  ICMJE June 29, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date June 7, 2013
Study Start Date  ICMJE June 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01633450 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zinc Absorption From Biofortified Rice
Official Title  ICMJE Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Other: Zinc biofortified rice
    1.12 mg zinc per meal
  • Other: Rice extrinsically fortified with zinc
    1.12 mg zinc per meal
Study Arms  ICMJE
  • Experimental: Zinc biofortified rice
    Intervention: Other: Zinc biofortified rice
  • Active Comparator: Rice extrinsically fortified with zinc
    Intervention: Other: Rice extrinsically fortified with zinc
Publications * Brnić M, Wegmüller R, Melse-Boonstra A, Stomph T, Zeder C, Tay FM, Hurrell RF. Zinc Absorption by Adults Is Similar from Intrinsically Labeled Zinc-Biofortified Rice and from Rice Fortified with Labeled Zinc Sulfate. J Nutr. 2016 Jan;146(1):76-80. doi: 10.3945/jn.115.213421. Epub 2015 Dec 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633450
Other Study ID Numbers  ICMJE HNL/CTC12-Reis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Study Sponsor  ICMJE Swiss Federal Institute of Technology
Collaborators  ICMJE University of Zurich
Investigators  ICMJE Not Provided
PRS Account Swiss Federal Institute of Technology
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP