HealthyNCT01576627
Zinc Absorption From Zinc Citrate, Zinc Gluconate and Zinc Oxide
A study testing zinc citrate, Zinc Gluconate and Zinc oxide in people with Healthy, run by Prof. Michael B. Zimmermann at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- zinc citrate, Zinc Gluconate and Zinc oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2012to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zinc Absorption From Zinc Supplements Comparing Zinc Citrate to Zinc Gluconate and Zinc Oxide in Young Adults
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.
- Conditions
- Healthy
- Being tested
- zinc citrate, Zinc Gluconate, Zinc oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc citrateDietary supplement
10 mg of zinc as either zinc citrate
Zinc GluconateDietary supplement
10 mg of zinc as either zinc gluconate
Zinc oxideDietary supplement
10 mg of zinc as either zinc oxide
| Study group | Role | What they receive |
|---|---|---|
| zinc citrate | Experimental | Not described Receives: Dietary Supplement: zinc citrate |
| zinc gluconate | Active comparator | Not described Receives: Dietary Supplement: Zinc Gluconate |
| zinc oxide | Active comparator | Not described Receives: Dietary Supplement: Zinc oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 61 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Michael B. Zimmermann
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor-investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576627
- Sponsor's protocol ID
- HNL/CTC11-12
- Status last verified
- Jan 2013
- First submitted
- 4 Apr 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24259556
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Absorption From Zinc Supplements Comparing Zinc Citrate to Zinc Gluconate and Zinc Oxide in Young Adults
- ClinicalTrials.gov ID
- NCT01576627
- Acronym / sponsor ID
- HNL/CTC11-12
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Prof. Michael B. ZimmermannUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Mar 2012
- Primary completion
- May 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zinc citrate | Experimental | Dietary Supplement: zinc citrate |
| zinc gluconate | Active comparator | Dietary Supplement: Zinc Gluconate |
| zinc oxide | Active comparator | Dietary Supplement: Zinc oxide |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc citrate10 mg of zinc as either zinc citrate | Dietary supplement | zinc citrate |
| Zinc Gluconate10 mg of zinc as either zinc gluconate | Dietary supplement | zinc gluconate |
| Zinc oxide10 mg of zinc as either zinc oxide | Dietary supplement | zinc oxide |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
- Derived from this study: PubMed 24259556Wegmuller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc citrate, Zinc Gluconate and Zinc oxide in people with Healthy, run by Prof. Michael B. Zimmermann at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional absorption of zinc (time frame: 61 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01576627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.