Generalized Chronic PeriodontitisProtocol01NCT03162406
Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis
A study testing Vitamin D3 in people with Generalized Chronic Periodontitis and Vitamin D Deficiency, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The subjects participating in the trial will be randomly allocated to either the group receiving the treatment under investigation (scaling and root planning (SRP) accompanied by administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction with placebo) as the control. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Generalized Chronic Periodontitis, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 18 May 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects who are in good general health and were diagnosed with GChP (generalized chronic periodontitis) based on the current classification of the AmericanAcademy of Periodontology will be included:
- ≥ 30 years of age,
- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction),
- a minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥ 5 mm,
- at least 30% of the sites with PPD and CAL ≥ 4 mm and bleeding on probing (BOP);
- Caucasians (defined as European and North African);
- subjects who present a 25(OH)D concentration < 30 ng/mL.
Who cannot join
- pregnancy
- breastfeeding
- current smoking and former smoking within the past 5 years-smoking status will be recorded as smoker (current) or non-smoker (never or former);
- systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
- SRP in the previous 12 months;
- antibiotic therapy in the previous 6 months;
Show all 13Show fewer
- long-term intake of anti-inflammatory medications;
- need for antibiotic pre-medication for routine dental therapy;
- any current ongoing immunological, neoplasia, endocrine, haematological, hepatic, renal, gastrointestinal, neurological, or psychiatric abnormalities or medical disease;
- subjects who used a UV light solarium or any type of vitamin D supplement within two months before the screening visit or planned to travel outside European countries during the study
- subjets under treatment with drugs that may interfere with vitamin D metabolism (e.g., phenobarbital, phenytoin, and glucocorticoids) and those with past or current history of granulomatosis, especially sarcoidosis, urinary lithiasis, and osteomalacia;
- subjects who present a 25(OH)D concentration > 30 ng/mL, serum creatinine >150 mmol/L and and albumin corrected serum calcium >2.65 mmol/L (corresponding to 10.6 mg/dL) at screening,
- any sensitivity or allergy to any of the products that will be used in the study or a history of drug and/or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Jérôme Lasserre, PhD, 00322764 ext. 5719, jerome.lasserre@uclouvain.be
Marina Peric, PhD, 00322764 ext. 5719, marina.peric@uclouvain.be
About this study
Official title: Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis: A Randomized Double-blinded Placebo Controlled Clinical Trial
The subjects participating in the trial will be randomly allocated to either the group receiving the treatment under investigation (scaling and root planning (SRP) accompanied by administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction with placebo) as the control. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins. After randomization, the two groups of subjects will be followed in exactly the same way and the only differences between them will be the vitamin D/placebo that they will receive.
Read the detailed description
It is likely that a chronically low intake of vitamin D and calcium may lead to a negative calcium balance, thus causing a secondary increase in calcium removal from bone, including the alveolar bone. Such bone loss may contribute to weakening of the tooth-attachment apparatus. In addition to its action on skeletal homeostasis, vitamin D, and, in particular, its hormonally active form, 1a,25-dihydroxyvitamin D, has anti-inflammatory and antimicrobial effects via modulation of inflammatory cytokine production by immune cells and stimulated secretion of peptides with antibacterial action by cells of the monocyte-macrophage lineage.These multiple actions of vitamin D are potentially appealing for the management of patients with periodontal disease, whose pathogenesis is based on chronic bacterial-driven inflammation.
Excess of vitamin D leads to a disturbance of the calcium in the body cycle. The symptoms experienced are: weakness, fatigue, headache, nausea, vomiting, diarrhea, polyuria, calciuria, dry mouth, nighttime urination, proteinuria, increased thirst, loss ofappetite, dizziness.
In case of high blood calcium level for a prolonged period, calcium deposits (tissue calcinosis) may occur in the soft tissues, including the kidneys where they cause calculations and calcium deposits in the nephrons, blood vessels, heart, lung and skin. These effects are reversible if the intoxication is detected in time.
- Being tested
- Vitamin D3, Placebo
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
Oral supplementation 25000 IU once per week for 6 months
PlaceboDietary supplement
Also called Clear, slightly yellow, oily liquid with an orange odour
Oral supplementation once per week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | Procedure: SRP Dietary Supplement: Vitamin D3 Oral supplementation 25000 IU once per week for 6 months Other Name: Cholecalciferol Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Procedure: SRP Dietary Supplement: Placebo Oral supplementation once per week for 6 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm
Measured: up to 6 months
Secondary outcomes (13)
Number of sites with PPD ≥ 5 mm
Measured: up to 6 months
Number of sites with PPD ≥ 6 mm
Measured: up to 6 months
Number of sites with PPD ≥ 7 mm
Measured: up to 6 months
Reduction in the number of sites with PPD ≥ 5 mm
Measured: up to 6 months
Reduction in the number of sites with PPD ≥ 6 mm
Measured: up to 6 months
Reduction in the number of sites with PPD ≥ 7 mm
Measured: up to 6 months
Full-mouth PPD
Measured: up to 6 months
Full-mouth CAL
Measured: up to 6 months
Percentage of sites with BOP
Measured: up to 6 months
Percentage of sites with plaque accumulation
Measured: up to 6 months
Serum vitamin D concentration
Measured: 1 month before treatment and up to 6 months
Serum high-sensitivity C-reactive Protein (hs-CRP)
Measured: 1 month before treatment, at baseline, at 6 months
Serum high-density lipoprotein (HDL) cholesterol
Measured: 1 month before treatment, at baseline, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start18 May 2017
- Primary completion30 Jun 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Lasserre, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de LouvainEtienne Cavalier, PhD, Study chair, Professor and Head of the Department of Clinical Chemistry, CHU Sart-Tilman Liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162406
- Sponsor's protocol ID
- 2017/06JAN/013
- Acronym
- Protocol01
- Status last verified
- May 2017
- First submitted
- 19 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be decided at the end of the study
Publications
Peric M, Maiter D, Cavalier E, Lasserre JF, Toma S. The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study. Nutrients. 2020 Sep 25;12(10):2940. doi: 10.3390/nu12102940.
PubMed 32992785
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis: A Randomized Double-blinded Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03162406
- Acronym / sponsor ID
- Protocol01 / 2017/06JAN/013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 18 May 2017 (actual)
- Primary completion
- 30 Jun 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The subjects participating in the trial will be randomly allocated to either the group receiving the treatment under investigation (scaling and root planning (SRP) accompanied by administration of vitamin D) or to a group receiving standard treatment (SRP in conjunction with placebo) as the control. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited, but before the intervention to be studied begins. After randomization, the two groups of subjects will be followed in exactly the same way and the only differences between them will be the vitamin D/placebo that they will receive.
Detailed description
It is likely that a chronically low intake of vitamin D and calcium may lead to a negative calcium balance, thus causing a secondary increase in calcium removal from bone, including the alveolar bone. Such bone loss may contribute to weakening of the tooth-attachment apparatus. In addition to its action on skeletal homeostasis, vitamin D, and, in particular, its hormonally active form, 1a,25-dihydroxyvitamin D, has anti-inflammatory and antimicrobial effects via modulation of inflammatory cytokine production by immune cells and stimulated secretion of peptides with antibacterial action by cells of the monocyte-macrophage lineage.These multiple actions of vitamin D are potentially appealing for the management of patients with periodontal disease, whose pathogenesis is based on chronic bacterial-driven inflammation.
Excess of vitamin D leads to a disturbance of the calcium in the body cycle. The symptoms experienced are: weakness, fatigue, headache, nausea, vomiting, diarrhea, polyuria, calciuria, dry mouth, nighttime urination, proteinuria, increased thirst, loss ofappetite, dizziness.
In case of high blood calcium level for a prolonged period, calcium deposits (tissue calcinosis) may occur in the soft tissues, including the kidneys where they cause calculations and calcium deposits in the nephrons, blood vessels, heart, lung and skin. These effects are reversible if the intoxication is detected in time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Dietary Supplement: Vitamin D3Procedure: SRP Dietary Supplement: Vitamin D3 Oral supplementation 25000 IU once per week for 6 months Other Name: Cholecalciferol |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboProcedure: SRP Dietary Supplement: Placebo Oral supplementation once per week for 6 months |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects who are in good general health and were diagnosed with GChP (generalized chronic periodontitis) based on the current classification of the AmericanAcademy of Periodontology will be included:
- ≥ 30 years of age,
- at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction),
- a minimum of 6 teeth with at least one site each with periodontal probing depth (PPD) and clinical attachment level (CAL) ≥ 5 mm,
- at least 30% of the sites with PPD and CAL ≥ 4 mm and bleeding on probing (BOP);
Key exclusion criteria (13 listed)
- pregnancy
- breastfeeding
- current smoking and former smoking within the past 5 years-smoking status will be recorded as smoker (current) or non-smoker (never or former);
- systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
- SRP in the previous 12 months;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: CholecalciferolOral supplementation 25000 IU once per week for 6 months | Dietary supplement | Vitamin D |
| PlaceboAlso: Clear, slightly yellow, oily liquid with an orange odourOral supplementation once per week for 6 months | Dietary supplement | Placebo |
Primary outcome
Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm
Time frame: up to 6 months
13 secondary outcomes
Number of sites with PPD ≥ 5 mm
Time frame: up to 6 months
Number of sites with PPD ≥ 6 mm
Time frame: up to 6 months
Number of sites with PPD ≥ 7 mm
Time frame: up to 6 months
Reduction in the number of sites with PPD ≥ 5 mm
Time frame: up to 6 months
Reduction in the number of sites with PPD ≥ 6 mm
Time frame: up to 6 months
Reduction in the number of sites with PPD ≥ 7 mm
Time frame: up to 6 months
Full-mouth PPD
Time frame: up to 6 months
Full-mouth CAL
Time frame: up to 6 months
Percentage of sites with BOP
Time frame: up to 6 months
Percentage of sites with plaque accumulation
Time frame: up to 6 months
Serum vitamin D concentration
Time frame: 1 month before treatment and up to 6 months
Serum high-sensitivity C-reactive Protein (hs-CRP)
Time frame: 1 month before treatment, at baseline, at 6 months
Serum high-density lipoprotein (HDL) cholesterol
Time frame: 1 month before treatment, at baseline, at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Derived from this study: PubMed 32992785Peric M, Maiter D, Cavalier E, Lasserre JF, Toma S. The Effects of 6-Month Vitamin D Supplementation during the Non-Surgical Treatment of Periodontitis in Vitamin-D-Deficient Patients: A Randomized Double-Blind Placebo-Controlled Study. Nutrients. 2020 Sep 25;12(10):2940. doi: 10.3390/nu12102940.
- Individual participant dataSharing planned: Undecided. It will be decided at the end of the study
Related trials for Generalized Chronic Periodontitis
RecruitingPhase 2
3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Periodontitis Stage II, Periodontitis Stage III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Lasserre, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Etienne Cavalier, PhD study chair
Professor and Head of the Department of Clinical Chemistry, CHU Sart-Tilman Liège
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Generalized Chronic Periodontitis and Vitamin D Deficiency, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jérôme Lasserre, PhD (00322764 ext. 5719, jerome.lasserre@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.