Zinc Absorption From Biofortified Rice

This study has been completed.

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: June 6, 2013

Last verified: June 2013

History of Changes

Purpose

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	Intervention
Healthy	Other: Zinc biofortified rice Other: Rice extrinsically fortified with zinc


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
Official Title:	Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study

Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:

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.


Enrollment:	16
Study Start Date:	June 2012
Study Completion Date:	October 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633450

Locations


Switzerland
ETH Zurich
Zurich, Switzerland

Sponsors and Collaborators

Swiss Federal Institute of Technology

University of Zurich

More Information

No publications provided


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
Study First Received:	June 29, 2012
Last Updated:	June 6, 2013
Health Authority:	Switzerland: Ethikkommission

Additional relevant MeSH terms:


Zinc Growth Substances Micronutrients	Pharmacologic Actions Physiological Effects of Drugs Trace Elements

ClinicalTrials.gov processed this record on March 03, 2015

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