CompletedNot Applicable

Occurrence of Selected Vitamins in Saliva and Blood

Germany50 participantsStarted 2015-11

Plain-language 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. 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.

Who can participate

Age range

20 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Identify and quantify selected forms of vitamins in saliva and blood/plasma samples

Timeframe: 1 day

Trial details

NCT IDNCT02592148

Sponsordsm-firmenich Switzerland AG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-12

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