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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01576627
Other study ID # HNL/CTC11-12
Secondary ID
Status Completed
Phase N/A
First received April 4, 2012
Last updated January 3, 2013
Start date March 2012
Est. completion date November 2012

Study information

Verified date January 2013
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
zinc citrate
10 mg of zinc as either zinc citrate
Zinc Gluconate
10 mg of zinc as either zinc gluconate
Zinc oxide
10 mg of zinc as either zinc oxide

Locations

Country Name City State
Switzerland ETH Zurich Zurich

Sponsors (2)

Lead Sponsor Collaborator
Prof. Michael B. Zimmermann University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional absorption of zinc 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. 61 days No
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