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Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis (Protocol01)

Primary Purpose

Generalized Chronic Periodontitis, Vitamin D Deficiency

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Vitamin D3

Placebo

About this trial

This is an interventional treatment trial for Generalized Chronic Periodontitis

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Sites / Locations

Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

Procedure: SRP Dietary Supplement: Vitamin D3 Oral supplementation 25000 IU once per week for 6 months Other Name: Cholecalciferol

Procedure: SRP Dietary Supplement: Placebo Oral supplementation once per week for 6 months

Outcomes

Primary Outcome Measures

Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm

Secondary Outcome Measures

Number of sites with PPD ≥ 5 mm

Number of sites with PPD ≥ 6 mm

Number of sites with PPD ≥ 7 mm

Reduction in the number of sites with PPD ≥ 5 mm

Reduction in the number of sites with PPD ≥ 6 mm

Reduction in the number of sites with PPD ≥ 7 mm

Full-mouth PPD

Full-mouth CAL

Percentage of sites with BOP

Percentage of sites with plaque accumulation

Serum vitamin D concentration

Serum high-sensitivity C-reactive Protein (hs-CRP)

Serum high-density lipoprotein (HDL) cholesterol

Full Information

NCT ID

NCT03162406

First Posted

May 19, 2017

Last Updated

May 22, 2017

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03162406

Brief Title

Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis

Acronym

Protocol01

Official Title

Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis: A Randomized Double-blinded Placebo Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

May 18, 2017 (Actual)

Primary Completion Date

June 30, 2018 (Anticipated)

Study Completion Date

June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Chronic Periodontitis, Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Parallel assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D

Arm Type

Experimental

Arm Description

Procedure: SRP Dietary Supplement: Vitamin D3 Oral supplementation 25000 IU once per week for 6 months Other Name: Cholecalciferol

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Procedure: SRP Dietary Supplement: Placebo Oral supplementation once per week for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D3

Other Intervention Name(s)

Cholecalciferol

Intervention Description

Oral supplementation 25000 IU once per week for 6 months

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Clear, slightly yellow, oily liquid with an orange odour

Intervention Description

Oral supplementation once per week for 6 months

Primary Outcome Measure Information:

Title

Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Number of sites with PPD ≥ 5 mm

Time Frame

up to 6 months

Title

Number of sites with PPD ≥ 6 mm

Time Frame

up to 6 months

Title

Number of sites with PPD ≥ 7 mm

Time Frame

up to 6 months

Title

Reduction in the number of sites with PPD ≥ 5 mm

Time Frame

up to 6 months

Title

Reduction in the number of sites with PPD ≥ 6 mm

Time Frame

up to 6 months

Title

Reduction in the number of sites with PPD ≥ 7 mm

Time Frame

up to 6 months

Title

Full-mouth PPD

Time Frame

up to 6 months

Title

Full-mouth CAL

Time Frame

up to 6 months

Title

Percentage of sites with BOP

Time Frame

up to 6 months

Title

Percentage of sites with plaque accumulation

Time Frame

up to 6 months

Title

Serum vitamin D concentration

Time Frame

1 month before treatment and up to 6 months

Title

Serum high-sensitivity C-reactive Protein (hs-CRP)

Time Frame

1 month before treatment, at baseline, at 6 months

Title

Serum high-density lipoprotein (HDL) cholesterol

Time Frame

1 month before treatment, at baseline, at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jérôme Lasserre, PhD

Phone

00322764

Ext

5719

jerome.lasserre@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Marina Peric, DMD

Phone

00322764

Ext

5719

marina.peric@student.uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jérôme Lasserre, PhD

Organizational Affiliation

Cliniques universitaires Saint-Luc

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Etienne Cavalier, PhD

Organizational Affiliation

Professor and Head of the Department of Clinical Chemistry, CHU Sart-Tilman Liège

Official's Role

Study Chair

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jérôme Lasserre, PhD

Phone

00322764

Ext

5719

jerome.lasserre@uclouvain.be

First Name & Middle Initial & Last Name & Degree

Marina Peric, PhD

Phone

00322764

Ext

5719

marina.peric@uclouvain.be

First Name & Middle Initial & Last Name & Degree

Selena Toma, PhD

First Name & Middle Initial & Last Name & Degree

Dominique Maiter, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

It will be decided at the end of the study

Citations:

PubMed Identifier

32992785

Citation

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.

Results Reference

derived

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Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis

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