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Completed

NCT Number: NCT04655664

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

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.

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Key information

Conditions

Nutritional Deficiency Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatra, 20155, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

not currently consumed vitamin D supplements regularly

Diagnostic Test

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.

consumed vitamin D supplements regularly

Diagnostic Test

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 outcomes

  1. Salivary 25 (OH) D

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universitas Sumatera Utara

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2020
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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