Study on the Effects of Vitamin D3 in Patients with Periodontitis and Vitamin D Deficiency

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What is this study about?

This clinical trial is focused on studying the effects of vitamin D3 supplementation in individuals with periodontitis and a deficiency in vitamin D. Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth. The treatment being tested is a supplement called vitamin D3, also known as colecalciferol, which is a form of vitamin D that helps the body absorb calcium and maintain bone health. Participants in the study will receive either the vitamin D3 supplement or a placebo, which is a substance with no active therapeutic effect.

The purpose of the study is to evaluate how effective vitamin D3 is when used alongside standard non-surgical treatments for periodontitis. The study will last for 24 weeks, during which participants will take the supplement or placebo orally in the form of hard capsules. Throughout the study, participants will have regular check-ups to monitor their gum health and vitamin D levels. The main focus will be on changes in the depth of gum pockets, which are spaces that can form between the teeth and gums due to periodontitis.

By the end of the study, researchers aim to determine if vitamin D3 can help improve gum health in people with periodontitis and vitamin D deficiency. This could potentially lead to better treatment options for managing this common dental condition. Participants will be closely monitored for any side effects or changes in their health during the trial period.

1 joining the study

Upon joining the study, participants are required to provide written informed consent. This involves signing a form to confirm understanding and agreement to participate in the trial.

2 initial assessment

Participants undergo an initial assessment to confirm eligibility. This includes verifying a diagnosis of stage III or IV periodontitis and a vitamin D level of 20 ng/mL or lower.

3 baseline visit (V2)

At the baseline visit, participants receive a non-surgical periodontal treatment. Measurements of probing pocket depth (PPD) are taken to establish a starting point for the study.

4 medication administration

Participants are randomly assigned to receive either vitamin D3 (colecalciferol) or a placebo. The medication is administered orally in the form of a hard capsule, with a dosage of 25,000 IU. The frequency and duration of administration are determined by the study protocol.

5 follow-up visit at week 12 (V3)

Participants return for a follow-up visit at week 12. During this visit, changes in probing pocket depth and clinical attachment level are assessed. Blood samples may be taken to measure vitamin D levels.

6 final assessment at week 24 (V4)

The final assessment occurs at week 24. The primary focus is on changes in the number of residual probing pocket depths of 5mm or greater. Secondary assessments include changes in clinical attachment level, bleeding on probing, and plaque control.

7 end of trial

The trial concludes with a review of all collected data. Participants are monitored for any adverse events throughout the study duration.

Who Can Join the Study?

Must be a Caucasian male or female over 18 years old.
Must have a confirmed diagnosis of stage III or IV periodontitis. This is a condition affecting the gums and bones that support the teeth, diagnosed within the last 2 months before the screening.
Must have more than 15 natural teeth in the mouth.
Must have a level of 25(OH)D3 that is 20 ng/mL or lower at the screening visit. This is a measure of vitamin D in the blood.
Must be able to follow all the procedures required by the trial.
Must provide written informed consent to participate in the trial, which means signing and dating a form to show understanding and agreement to join the study.
If the participant is a woman who can have children, she must use a highly effective method of birth control from the screening visit until at least 28 days after the last dose of the study product.

Who Cannot Join the Study?

Individuals who are not within the specified age range for the study.
Individuals who do not have a diagnosis of periodontitis, which is a serious gum infection that damages the soft tissue and can destroy the bone that supports your teeth.
Individuals who are part of a vulnerable population, meaning groups that may need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centre hospitalier universitaire de Liege	Liege	Belgium
Cmjdzjtmq Uehlocphadavfw Sazzrhpsh	Woluwe-Saint-Lambert	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

Colecalciferol

Vitamin D3 is being studied as an additional treatment for people with periodontitis who also have a vitamin D deficiency. The trial aims to see if taking vitamin D3 can help improve the condition of the gums when used alongside standard non-surgical periodontal treatments.

Periodontitis – Periodontitis is a common gum disease that affects the tissues surrounding and supporting the teeth. It begins with inflammation of the gums, known as gingivitis, and can progress to more severe stages if untreated. As the disease advances, the gums pull away from the teeth, forming spaces called pockets that become infected. The body’s immune response to the infection can lead to the breakdown of bone and connective tissue that hold teeth in place. Over time, this can result in tooth loss if the supporting structures are destroyed. The progression of periodontitis is often slow and can be influenced by factors such as oral hygiene, smoking, and genetic predisposition.

Trial ID:

2023-503671-16-00

Protocol code:

D-CURE-IV-22-1

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Vitamin D3 in Patients with Periodontitis and Vitamin D Deficiency

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?