Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

3 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Vitamin D3 – This medication is administered orally, typically in the form of capsules or tablets. It is currently being studied in clinical trials for its potential benefits in treating periodontitis, particularly in individuals with vitamin D deficiency. The main therapeutic indication is as an adjunct therapy to non-surgical periodontal treatment, aiming to reduce the depth of periodontal pockets. At the molecular level, Vitamin D3 helps regulate calcium and phosphate balance in the body, which is crucial for maintaining healthy bones and teeth. It is classified as a vitamin supplement and is widely recognized for its role in supporting bone health and immune function.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503671-16-00Protocol codeD-CURE-IV-22-1Estimated enrolment82 patientsSponsorLaboratoires S.M.B.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.