Occurrence of Selected Vitamins in Saliva and Blood

NCT ID: NCT02592148

Last Updated: 2016-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-02-29

Brief Summary

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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

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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

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Divorced State

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Health subjects

Male and female

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Menzel, Dr.

Role: PRINCIPAL_INVESTIGATOR

BioTeSys

Locations

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BioTeSys

Esslingen am Neckar, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BTS829/14

Identifier Type: -

Identifier Source: org_study_id

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