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The Use of the 25 (OH) D Saliva Test as a Substitute for the 25 (OH) D Serum Test in Healthy People

Primary Purpose

Nutritional Deficiency

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
not currently consumed vitamin D supplements regularly
consumed vitamin D supplements regularly
Sponsored by
Universitas Sumatera Utara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nutritional Deficiency focused on measuring vitamin D, cross-sectional, non-invasive, correlation, deficiency, insufficiency

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • men and women aged 18-60 years, not currently experiencing chronic pain, kidney problems, liver problems, or other hormone disorders.

Exclusion Criteria:

  • subjects who consumed vitamin D supplements regularly, were pregnant, or were breastfeeding.

Sites / Locations

  • Faculty of Medicine Universitas Sumatera Utara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Group

Regularly Group

Arm Description

Men and women aged 18-60 years, not currently experiencing chronic pain, kidney problems, liver problems, or other hormone disorders

Subjects who consumed vitamin D supplements regularly, were pregnant, or were breastfeeding.

Outcomes

Primary Outcome Measures

Salivary 25 (OH) D
Salivary 25 (OH) D assay can be used to replace serum 25 (OH) D assay in healthy people as a non-invasive alternative. Examination using saliva as a substitute for serum testing is expected to facilitate the examination of 25 (OH) D.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2020
Last Updated
December 1, 2020
Sponsor
Universitas Sumatera Utara
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1. Study Identification

Unique Protocol Identification Number
NCT04655664
Brief Title
The Use of the 25 (OH) D Saliva Test as a Substitute for the 25 (OH) D Serum Test in Healthy People
Official Title
The Use of the 25 (OH) D Saliva Test as a Substitute for the 25 (OH) D Serum Test in Healthy People
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
April 11, 2020 (Actual)
Primary Completion Date
June 8, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sumatera Utara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Routine examination of vitamin D levels is carried out by checking serum 25 (OH)D levels, which indicate circulating vitamin D levels. While serum 1.25 (OH) D levels are less frequently utilized, they represent the active form of vitamin D and could be a substitute for checking vitamin D levels. This study aims to find the correlation between vitamin D levels, namely 25 (OH) D and 1.25 (OH) D saliva, which correlate with serum 25 (OH) D and 1.25 (OH) D levels in the examination of salivary vitamin D, and which could be a substitute for checking serum vitamin D levels.
Detailed Description
Routine examination of vitamin D levels is carried out by checking serum 25 (OH)D levels, which indicate circulating vitamin D levels. While serum 1.25 (OH) D levels are less frequently utilized, they represent the active form of vitamin D and could be a substitute for checking vitamin D levels.This study aims to find the correlation between vitamin D levels, namely 25 (OH) D and 1.25 (OH) D saliva, which correlate with serum 25 (OH) D and 1.25 (OH) D levels in the examination of salivary vitamin D, and which could be a substitute for checking serum vitamin D levels.This study is a cross-sectional study involving healthy men and women, aged 20-50 years, from Lima Puluh Village, Batubara District, North Sumatra Province, Indonesia. The parameters studied were 25 (OH) D and 1.25 (OH) D levels of saliva and serum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nutritional Deficiency
Keywords
vitamin D, cross-sectional, non-invasive, correlation, deficiency, insufficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Men and women aged 18-60 years, not currently experiencing chronic pain, kidney problems, liver problems, or other hormone disorders
Arm Title
Regularly Group
Arm Type
Active Comparator
Arm Description
Subjects who consumed vitamin D supplements regularly, were pregnant, or were breastfeeding.
Intervention Type
Diagnostic Test
Intervention Name(s)
not currently consumed vitamin D supplements regularly
Intervention Description
The tests carried out were examination of 25 (OH) D and 1.25 (OH) D levels of serum and saliva, examination of demographic data, and other anthropometries. The examination was carried out by taking 5 mL of blood and 2 mL of saliva, and then checking the serum and saliva levels of 25 (OH) D and 1.25 (OH) D. Before the examination, the research subjects were asked not to consume food or drink for at least 90 minutes before being examined. Centrifugation was carried out (2500 g, 10 minutes) and the product immediately stored at -20 oC. In the serum examination, after the blood was drawn, centrifugation was carried out and the product stored at -20 oC for further determination of the levels of 25 (OH) D and 1.25 (OH) saliva.
Intervention Type
Diagnostic Test
Intervention Name(s)
consumed vitamin D supplements regularly
Intervention Description
The tests carried out were examination of 25 (OH) D and 1.25 (OH) D levels of serum and saliva, examination of demographic data, and other anthropometries. The examination was carried out by taking 5 mL of blood and 2 mL of saliva, and then checking the serum and saliva levels of 25 (OH) D and 1.25 (OH) D. Before the examination, the research subjects were asked not to consume food or drink for at least 90 minutes before being examined. Centrifugation was carried out (2500 g, 10 minutes) and the product immediately stored at -20 oC. In the serum examination, after the blood was drawn, centrifugation was carried out and the product stored at -20 oC for further determination of the levels of 25 (OH) D and 1.25 (OH) saliva.
Primary Outcome Measure Information:
Title
Salivary 25 (OH) D
Description
Salivary 25 (OH) D assay can be used to replace serum 25 (OH) D assay in healthy people as a non-invasive alternative. Examination using saliva as a substitute for serum testing is expected to facilitate the examination of 25 (OH) D.
Time Frame
up to 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men and women aged 18-60 years, not currently experiencing chronic pain, kidney problems, liver problems, or other hormone disorders. Exclusion Criteria: subjects who consumed vitamin D supplements regularly, were pregnant, or were breastfeeding.
Facility Information:
Facility Name
Faculty of Medicine Universitas Sumatera Utara
City
Medan
State/Province
North Sumatra
ZIP/Postal Code
20155
Country
Indonesia

12. IPD Sharing Statement

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The Use of the 25 (OH) D Saliva Test as a Substitute for the 25 (OH) D Serum Test in Healthy People

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