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Zinc Absorption From Zinc Citrate, Zinc Gluconate and Zinc Oxide

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ClinicalTrials.gov Identifier: NCT01576627
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : January 4, 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 April 4, 2012
First Posted Date  ICMJE April 12, 2012
Last Update Posted Date January 4, 2013
Study Start Date  ICMJE March 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2012)		 Fractional absorption of zinc [ Time Frame: 61 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
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 Zinc Citrate, Zinc Gluconate and Zinc Oxide
Official Title  ICMJE Zinc Absorption From Zinc Supplements Comparing Zinc Citrate to Zinc Gluconate and Zinc Oxide in Young Adults
Brief Summary The goal of this trial is to evaluate zinc citrate, a zinc compound with promising sensory properties and a high zinc content, as an alternative zinc compound to be used for supplementation or food fortification. The bioavailability of zinc citrate given as a supplement to young Swiss adults will be assessed and compared to the bioavailability of the commonly used zinc compounds zinc gluconate and zinc oxide.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: zinc citrate
    10 mg of zinc as either zinc citrate
  • Dietary Supplement: Zinc Gluconate
    10 mg of zinc as either zinc gluconate
  • Dietary Supplement: Zinc oxide
    10 mg of zinc as either zinc oxide
Study Arms  ICMJE
  • Experimental: zinc citrate
    Intervention: Dietary Supplement: zinc citrate
  • Active Comparator: zinc gluconate
    Intervention: Dietary Supplement: Zinc Gluconate
  • Active Comparator: zinc oxide
    Intervention: Dietary Supplement: Zinc oxide
Publications * Wegmuller R, Tay F, Zeder C, Brnic M, Hurrell RF. Zinc absorption by young adults from supplemental zinc citrate is comparable with that from zinc gluconate and higher than from zinc oxide. J Nutr. 2014 Feb;144(2):132-6. doi: 10.3945/jn.113.181487. Epub 2013 Nov 20.

*   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: April 11, 2012)		 15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date May 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)
  • Vegans
  • 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 test supplement administration
  • 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 NCT01576627
Other Study ID Numbers  ICMJE HNL/CTC11-12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
Original Responsible Party Isabelle Aeberli, Swiss Federal Institute of Technology, ETH Zurich
Current Study Sponsor  ICMJE Prof. Michael B. Zimmermann
Original Study Sponsor  ICMJE Isabelle Aeberli
Collaborators  ICMJE University of Zurich
Investigators  ICMJE Not Provided
PRS Account Swiss Federal Institute of Technology
Verification Date January 2013

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