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

Not Applicable

Completed

• Conditions: Nutritional Deficiency
• Interventions: Diagnostic Test: consumed vitamin D supplements regularly; Diagnostic Test: not currently consumed vitamin D supplements regularly

• Registration Number: NCT04655664
• Lead Sponsor: Universitas Sumatera Utara

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.

Study Timeline

• Study Start: 2020-04-11
• Primary Completion: 2020-06-08
• Study Completion: 2020-09-15
• Study First Submitted: 2020-11-18
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-07
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regularly Group	consumed vitamin D supplements regularly	Subjects who consumed vitamin D supplements regularly, were pregnant, or were breastfeeding.
Treatment Group	not currently consumed vitamin D supplements regularly	Men and women aged 18-60 years, not currently experiencing chronic pain, kidney problems, liver problems, or other hormone disorders

Primary Outcome Measures

Name	Time	Method
Salivary 25 (OH) D	up to 2 weeks	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.

Trial Locations

Locations (1)

Faculty of Medicine Universitas Sumatera Utara; 🇮🇩 Medan, North Sumatra, Indonesia