Zinc Absorption From Biofortified Rice

This study is currently recruiting participants.

Verified June 2012 by Swiss Federal Institute of Technology

Sponsor:

Collaborator:

University of Zurich

Information provided by (Responsible Party):

Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

ClinicalTrials.gov Identifier:

NCT01633450

First received: June 29, 2012

Last updated: NA

Last verified: June 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	June 29, 2012
Last Updated Date	June 29, 2012
Start Date ^ICMJE	June 2012
Estimated 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 ] [ Designated as safety issue: No ] 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	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

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
Study Type ^ICMJE	Interventional
Study Phase
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
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 Arm (s)	Experimental: Zinc biofortified rice Intervention: Other: Zinc biofortified rice Active Comparator: Rice extrinsically fortified with zinc Intervention: Other: Rice extrinsically fortified with zinc
Publications *
* 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	Recruiting
Estimated Enrollment ^ICMJE	16
Estimated Completion Date	August 2012
Estimated 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
Gender	Both
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE
Location Countries ^ICMJE	Switzerland

Administrative Information
NCT Number ^ICMJE	NCT01633450
Other Study ID Numbers ^ICMJE	HNL/CTC12-Reis
Has Data Monitoring Committee
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
Information Provided By	Swiss Federal Institute of Technology
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top