Zinc DeficiencyNCT02292303
Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
A study testing zinc-enriched yeast and Zinc references in people with Zinc Deficiency, run by Lesaffre International.
Trial summary
The main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- zinc-enriched yeast and Zinc references
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Feb 2015
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Sex: female (premenopausal), male
- Age: 20 - 50 years
- BMI ≥19 or ≤30 kg/m²
- Non-smoker
- Subject is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry, hematology
Who cannot join
- Relevant history or presence of any medical disorder, potentially interfering with this trial
- For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Migraine or regular headache, intense premenstrual symptoms
- Coffee consumption >3 cups / day
- Blood donation within 2 months prior to trial start or during trial
- Regular intake of mineral supplements within 4 weeks prior to trial start or during trial
Show all 15Show fewer
- Chronic intake of substances affecting the intestinal absorption of zinc
- Vegetarians / vegans
- Drug-, alcohol- and medication abuses
- Known HIV-infection
- Known acute or chronic hepatitis B and C infection
- Relevant allergy or known hypersensitivity against compounds of the study preparations, for example lactose intolerance
- Known pregnancy, breast feeding or intention to become pregnant during the study
- Participation in another clinical trial within the last 4 weeks and concurrent participation in another clinical trial
- Not anticipating any planned changes in lifestyle for the duration of the study
About this study
Official title: Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
The main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.
- Conditions
- Zinc Deficiency
- Being tested
- zinc-enriched yeast, Zinc references
- Keywords
- Zinc/pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc-enriched yeastDietary supplement
Zinc referencesDietary supplement
Also called zinc oxide; zinc gluconate
| Study group | Role | What they receive |
|---|---|---|
| zinc-enriched yeast | Experimental | zinc-enriched yeast capsules Receives: Dietary Supplement: zinc-enriched yeast |
| zinc oxide | Active comparator | zinc oxide capsules Receives: Dietary Supplement: Zinc references |
| zinc gluconate | Active comparator | zinc gluconate capsules Receives: Dietary Supplement: Zinc references |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.
Measured: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min
Secondary outcomes (1)
Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc gluconate.
Measured: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zinc DeficiencyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lesaffre International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292303
- Sponsor's protocol ID
- BTS812/14
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 12 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Monocentric, Double-blind, 3-way-cross-over Clinical Trial to Determine the Bioavailability of Three Different Zinc Preparations
- ClinicalTrials.gov ID
- NCT02292303
- Acronym / sponsor ID
- BTS812/14
- Conditions
- Zinc Deficiency
- Keywords
- Zinc/pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lesaffre InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 17 Nov 2014 (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 main objective of this clinical is to get information on pharmacokinetics of zinc-enriched yeast.The bioavailability of the yeast enriched with zinc will be compared to two selected zinc salts used in food supplements that are zinc oxide and zinc gluconate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zinc-enriched yeast | Experimental | Dietary Supplement: zinc-enriched yeastzinc-enriched yeast capsules |
| zinc oxide | Active comparator | Dietary Supplement: Zinc referenceszinc oxide capsules |
| zinc gluconate | Active comparator | Dietary Supplement: Zinc referenceszinc gluconate capsules |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Sex: female (premenopausal), male
- Age: 20 - 50 years
- BMI ≥19 or ≤30 kg/m²
- Non-smoker
Key exclusion criteria (15 listed)
- Relevant history or presence of any medical disorder, potentially interfering with this trial
- For this trial clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Migraine or regular headache, intense premenstrual symptoms
- Coffee consumption >3 cups / day
- Blood donation within 2 months prior to trial start or during trial
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-enriched yeast | Dietary supplement | zinc-enriched yeast |
| Zinc referencesAlso: zinc oxide; zinc gluconate | Dietary supplement | zinc gluconate, zinc oxide |
Primary outcome
Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide.
Time frame: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min
1 secondary outcome
Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc gluconate.
Time frame: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min
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 12 Jun 2018.
Related trials for Zinc Deficiency
Active, not recruitingPhase 1
Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients
HIV
Active, not recruitingPhase 1
CD4 CAR+ ZFN-modified T Cells in HIV Therapy
Hiv
Recruiting
Zn Supplementation in HIV Immunological Non Responders
HIV, Zinc Status
Recruiting
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
Zinc Deficiency, Inflammation
RecruitingObservational study
Non-invasive Detection of Iron Deficiency in Obstetrics
Iron Deficiency Anemia of Pregnancy, Iron-deficiency
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.
Questions about this trial
What is this clinical trial studying?
A study testing zinc-enriched yeast and Zinc references in people with Zinc Deficiency, run by Lesaffre International.
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 6 inclusion and 15 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 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of pharmacokinetics parameters (AUC, Cmax and Tmax) between zinc-enriched yeast and zinc oxide. (time frame: Baseline (0 min); 30; 60; 90;120; 150; 180; 210; 240; 300 and 360 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2018.