Divorced StateSaliVitNCT02592148
Occurrence of Selected Vitamins in Saliva and Blood
An observational study of Divorced State, run by dsm-firmenich Switzerland AG at 1 site in Germany.
Trial summary
There is an interest to assess nutritional status of vitamins in humans in a non-invasive way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to blood for this purpose. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Divorced State
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2015to Feb 2016
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 50 subjects (females and males, with at least 40% of each gender) generally regarded as healthy in the age of 20 - 65 years.
Who may be able to join
- Generally healthy males and females
- Age: 20-65 years
- Non-smokers
- No recent or recently (within the last four weeks) started intake of vitamin supplements; long-term intake of supplements on regular base is o.k., but needs to be documented (type of supplement and dosage)
- Subjects willing and able to give written informed consent and to understand, to participate and to comply with the biomedical research project requirements.
Who cannot join
- Any condition that, in the investigator's opinion would impact volunteer safety and/or a volunteer's ability to complete all study related procedures. (e.g. psychiatric illness, drug addiction, alcoholism, etc.)
- Known infection with human immunodeficiency virus (HIV) or hepatitis.
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants, diuretics, thiazides), which in the investigator's opinion would impact volunteer safety
- Allergy or known hypersensitivity against disinfection solutions
- Women: pregnancy, or during lactation
- Currently participating in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Collection of Saliva and Blood Samples From Voluntary Donors to Establish the Occurrence of Selected Vitamins in Saliva and to Investigate Their Concentration Relative to Blood Levels
There is an interest to assess nutritional status of vitamins in humans in a non-invasive way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to blood for this purpose. The suitability of saliva for status determination will be investigated by analysis of (forms of) vitamins A and E, B1, B2, B3, B6 and C in both saliva and blood.
Read the detailed description
There is an interest to assess nutritional status of vitamins in humans in a non-invasive way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to blood for this purpose. However, literature data on vitamins in saliva is scarce. The occurrence is best demonstrated for 25-hydroxy-vitamin D3 where already indications for a correlation to blood levels have been observed in a small scale supplementation study. Occurrence of (forms of) vitamins A and E, B1, B2, B3, B6 and C has been reported but is less well documented. Some information is somewhat ambiguous and for none of these latter vitamins blood levels have been investigated in parallel to saliva.
- Conditions
- Divorced State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Health subjects | Male and female |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify and quantify selected forms of vitamins in saliva and blood/plasma samples
Selected forms of vitamins: vitamins A (retinol), E (alpha-tocopherol), D (25-hydroxy-vitamin D3), B1 (thiamine), B2 (riboflavine, FAD and FMN), B3 (nicotinic acid and nicotinamide), B6 (pyridoxal and pyridoxamine) and C (ascorbic acid). The measurement of this vitamin concentrations in blood/plasma and saliva will add to our knowledge of the occurrence or absence of these vitamins in saliva, and their concentration levels. Such information is only scarce in literature. Concentrations will be reported in ng/ml or microg/ml for each subject, and as mean for all participants.
Sampling of saliva, blood and plasma takes place at one time point only. Samples will be measured and reported within 3 month
Measured: 1 day
Secondary outcomes (1)
Determination of the relationship of saliva and blood/plasma concentrations of vitamins A, E, D, B1, B2, B3, B6 and C.
Concentrations measured in saliva and blood/plasma will be correlated to by e.g. linear regression models. The correlation coefficients will be reported. They give an indication on a possible positive relationship of saliva and blood/plasma status of vitamins in humans.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Divorced StateStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, Dr., Principal investigator, BioTeSys
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592148
- Sponsor's protocol ID
- BTS829/14
- Acronym
- SaliVit
- Status last verified
- Feb 2016
- First submitted
- 26 Oct 2015
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Saliva and Blood Samples From Voluntary Donors to Establish the Occurrence of Selected Vitamins in Saliva and to Investigate Their Concentration Relative to Blood Levels
- ClinicalTrials.gov ID
- NCT02592148
- Acronym / sponsor ID
- SaliVit / BTS829/14
- Conditions
- Divorced State
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 30 Oct 2015 (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.
There is an interest to assess nutritional status of vitamins in humans in a non-invasive way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to blood for this purpose. The suitability of saliva for status determination will be investigated by analysis of (forms of) vitamins A and E, B1, B2, B3, B6 and C in both saliva and blood.
Detailed description
There is an interest to assess nutritional status of vitamins in humans in a non-invasive way, i.e. by avoiding taking blood samples. Saliva could potentially be an alternative to blood for this purpose. However, literature data on vitamins in saliva is scarce. The occurrence is best demonstrated for 25-hydroxy-vitamin D3 where already indications for a correlation to blood levels have been observed in a small scale supplementation study. Occurrence of (forms of) vitamins A and E, B1, B2, B3, B6 and C has been reported but is less well documented. Some information is somewhat ambiguous and for none of these latter vitamins blood levels have been investigated in parallel to saliva.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health subjects | – | –Male and female |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 50 subjects (females and males, with at least 40% of each gender) generally regarded as healthy in the age of 20 - 65 years.
Key inclusion criteria (5 listed)
- Generally healthy males and females
- Age: 20-65 years
- Non-smokers
- No recent or recently (within the last four weeks) started intake of vitamin supplements; long-term intake of supplements on regular base is o.k., but needs to be documented (type of supplement and dosage)
- Subjects willing and able to give written informed consent and to understand, to participate and to comply with the biomedical research project requirements.
Key exclusion criteria (6 listed)
- Any condition that, in the investigator's opinion would impact volunteer safety and/or a volunteer's ability to complete all study related procedures. (e.g. psychiatric illness, drug addiction, alcoholism, etc.)
- Known infection with human immunodeficiency virus (HIV) or hepatitis.
- Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants, diuretics, thiazides), which in the investigator's opinion would impact volunteer safety
- Allergy or known hypersensitivity against disinfection solutions
- Women: pregnancy, or during lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify and quantify selected forms of vitamins in saliva and blood/plasma samples
Time frame: 1 day
Selected forms of vitamins: vitamins A (retinol), E (alpha-tocopherol), D (25-hydroxy-vitamin D3), B1 (thiamine), B2 (riboflavine, FAD and FMN), B3 (nicotinic acid and nicotinamide), B6 (pyridoxal and pyridoxamine) and C (ascorbic acid). The measurement of this vitamin concentrations in blood/plasma and saliva will add to our knowledge of the occurrence or absence of these vitamins in saliva, and their concentration levels. Such information is only scarce in literature. Concentrations will be reported in ng/ml or microg/ml for each subject, and as mean for all participants. Sampling of saliva, blood and plasma takes place at one time point only. Samples will be measured and reported within 3 month
1 secondary outcome
Determination of the relationship of saliva and blood/plasma concentrations of vitamins A, E, D, B1, B2, B3, B6 and C.
Time frame: 1 day
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 1 Mar 2016.
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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.
Daniel Menzel, Dr. principal investigator
BioTeSys
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Divorced State, run by dsm-firmenich Switzerland AG at 1 site in Germany.
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 5 inclusion and 6 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 1 Mar 2016. 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 Germany. 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?
Identify and quantify selected forms of vitamins in saliva and blood/plasma samples (time frame: 1 day). 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 1 Mar 2016.