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

NCT04655664 | Completed DMC

• 1 other identifier: USumateraUtara 1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutritional Deficiency

Keywords

vitamin D; cross-sectional; non-invasive; correlation; deficiency; insufficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Diagnostic Test: not currently consumed vitamin D supplements regularly

Regularly Group

ACTIVE COMPARATOR

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

Diagnostic Test: consumed vitamin D supplements regularly

Interventions

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.

Treatment Group

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.

Regularly Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Sumatera Utara: lead

Study Sites (1)

Faculty of Medicine Universitas Sumatera Utara

Medan, North Sumatra, 20155, Indonesia

Location

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: December 7, 2020
• Study Start: April 11, 2020
• Primary Completion: June 8, 2020
• Study Completion: September 15, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

ID (1)