Effect of Vitamin D supplementation in participants with periodontitis and vitamin D deficiency.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Laboratoires S.M.B.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Stomatognathic Diseases [C07]

Trial duration

15 Dec 2023 → ongoing

Decision date (initial)

2023-12-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The primary objective is to evaluate the efficacy of vitamin D3 as an adjunct therapy to a non-surgical periodontal treatment in the number of residual probing pocket depth ≥ 5mm in participants with chronic periodontitis.

Secondary objectives 3

1. To monitor the changes in secondary periodontal indices: probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BoP), plaque control (O’Leary), PPD ≥ 6, 5 or 4 mm.
2. To monitor the change in 25(OH)D3 serum concentration.
3. To follow the overall safety of the products (D-CURE® and placebo)

Conditions and MedDRA coding

Periodontitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Caucasian male and female over 18 years old (18 years inclusive).
2. Adult participants with confirmed diagnosis of stage III or IV periodontitis based on the classification of the European Federation of Periodontology within the last 2 months prior screening.
3. Presenting more than 15 natural teeth in the mouth.
4. Having a 25(OH)D3 < 30 ng/mL at the screening visit.
5. Able to comply with all trial procedures.
6. Provide written informed consent to participate in the trial, indicated by a personal signature and date on the informed consent form.
7. If participant is a woman of childbearing potential, participant must use a highly effective contraception from screening visit until at least 28 days following the last dose of the investigational product as defined in section 13.1.2 of the Clinical Trial Protocol.

Exclusion criteria 15

1. Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease that would affect the progression of periodontitis.
2. Past or current granulomatosis (Besnier-Boek-Schaumann disease), sarcoidosis, nephrolithiasis, nephrocalcinosis, renal impairment or insufficiency, osteomalacia, pseudohypoparathyroidism.
3. Participants with fixed or removable orthodontic appliances.
4. History of active periodontal treatment (including non-surgical and surgical therapy) within the last 6 months prior screening.
5. Planned tooth extraction after visit 2. Any tooth extraction should be performed no later than randomization day/treatment start if necessary.
6. Smokers of more than 10 cigarettes per day
7. Hypercalcemia at screening.
8. Systemic antibiotic prophylaxis prior treatment or systemic antibiotic for maxillofacial-ENT (ear, nose and throat) infections in the previous 3 months prior screening.
9. Use of any vitamin D supplementation alone or in association.
10. Chronic use of aspirin and/or NSAIDs.
11. Use of any prohibited medication as detailed in the section 6.8.1 of the clinical trial protocol.
12. UV light solarium use 4 weeks before the screening visit.
13. Pregnancy or lactating females.
14. Participants with any sensitivity or allergy to any of the active ingredients and/or excipients present in the products used within this clinical trial.
15. Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute change from baseline (V2) to week 24 (V4) in the number of residual PPD ≥ 5mm.

Secondary endpoints 12

1. Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean probing pocket depth (PPD).
2. Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the mean clinical attachment level (CAL).
3. Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 4mm
4. Absolute change from baseline (V2) to week 12 (V3) in the number of residual PPD ≥ 5mm.
5. Absolute change from baseline (V2) to week 12 (V3) and week 24 (V4) in the number of residual PPD ≥ 6mm
6. Absolute change from baseline (V2) to week 12 (V3) and 24 (V4) on the bleeding on probing (BoP)
7. Absolute change from baseline to week 12 (V3) and 24 (V4) on the plaque control (O’Leary)
8. Percentage of participants with ≤4 sites with PPD ≥ 5mm at week 24 (V4)
9. Absolute change from baseline (V1) to week 12 (V3) and 24 (V4) in the 25(OH)D3 serum concentration.
10. Percentage of participants reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 24 (V4).
11. Incidence in adverse events including adverse events (AEs), serious adverse events (SAEs), and suspected unexpected serious adverse reactions (SUSARs).
12. Change from baseline in laboratory data including the assessment of serum concentration of calcium and phosphate throughout the clinical trial.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Laboratoires S.M.B.

Sponsor organisation

Laboratoires S.M.B.

Address

Herdersliedstraat 26-28

City

Sint-Jans-Molenbeek

Postcode

1080

Country

Belgium

Scientific contact point

Organisation

Laboratoires S.M.B.

Contact name

Sophie De Niet

Public contact point

Organisation

Laboratoires S.M.B.

Contact name

Sophie De Niet

Third parties 4

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications