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Occurrence of Selected Vitamins in Saliva and Blood (SaliVit)

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ClinicalTrials.gov Identifier: NCT02592148
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : March 1, 2016
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

Brief 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.

Condition or disease
Divorced State

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Study Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : February 2016

Group/Cohort
Health subjects
Male and female



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592148


Locations
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Germany
BioTeSys
Esslingen, Germany, 73728
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Daniel Menzel, Dr. BioTeSys
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Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT02592148    
Other Study ID Numbers: BTS829/14
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: March 1, 2016
Last Verified: February 2016