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

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.

Study Overview

• Status: Unknown
• Conditions: Vitamin D Deficiency; Generalized Chronic Periodontitis
• Intervention / Treatment: Dietary supplement: Vitamin D3; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques universitaires Saint-Luc
    • Contact: Jérôme Lasserre, PhD; Phone Number: 5719 00322764; Email: jerome.lasserre@uclouvain.be
    • Contact: Marina Peric, PhD; Phone Number: 5719 00322764; Email: marina.peric@uclouvain.be
    • Sub-Investigator: Selena Toma, PhD
    • Sub-Investigator: Dominique Maiter, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D; Procedure: SRP Dietary Supplement: Vitamin D3 Oral supplementation 25000 IU once per week for 6 months Other Name: Cholecalciferol	Dietary supplement: Vitamin D3; Oral supplementation 25000 IU once per week for 6 months; Other Names: Cholecalciferol
Placebo Comparator: Placebo; Procedure: SRP Dietary Supplement: Placebo Oral supplementation once per week for 6 months	Dietary supplement: Placebo; Oral supplementation once per week for 6 months; Other Names: Clear, slightly yellow, oily liquid with an orange odour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm	up to 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of sites with PPD ≥ 5 mm	up to 6 months
Number of sites with PPD ≥ 6 mm	up to 6 months
Number of sites with PPD ≥ 7 mm	up to 6 months
Reduction in the number of sites with PPD ≥ 5 mm	up to 6 months
Reduction in the number of sites with PPD ≥ 6 mm	up to 6 months
Reduction in the number of sites with PPD ≥ 7 mm	up to 6 months
Full-mouth PPD	up to 6 months
Full-mouth CAL	up to 6 months
Percentage of sites with BOP	up to 6 months
Percentage of sites with plaque accumulation	up to 6 months
Serum vitamin D concentration	1 month before treatment and up to 6 months
Serum high-sensitivity C-reactive Protein (hs-CRP)	1 month before treatment, at baseline, at 6 months
Serum high-density lipoprotein (HDL) cholesterol	1 month before treatment, at baseline, at 6 months

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Jérôme Lasserre, PhD, Cliniques universitaires Saint-Luc; Study Chair: Etienne Cavalier, PhD, Professor and Head of the Department of Clinical Chemistry, CHU Sart-Tilman Liège

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Periodontitis; Vitamin D Deficiency; Chronic Periodontitis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 2017/06JAN/013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It will be decided at the end of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No