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

May 22, 2017 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-luc
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Selena Toma, PhD
        • Sub-Investigator:
          • Dominique Maiter, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of sites with PPD ≥ 5 mm
Time Frame: up to 6 months
up to 6 months
Number of sites with PPD ≥ 6 mm
Time Frame: up to 6 months
up to 6 months
Number of sites with PPD ≥ 7 mm
Time Frame: up to 6 months
up to 6 months
Reduction in the number of sites with PPD ≥ 5 mm
Time Frame: up to 6 months
up to 6 months
Reduction in the number of sites with PPD ≥ 6 mm
Time Frame: up to 6 months
up to 6 months
Reduction in the number of sites with PPD ≥ 7 mm
Time Frame: up to 6 months
up to 6 months
Full-mouth PPD
Time Frame: up to 6 months
up to 6 months
Full-mouth CAL
Time Frame: up to 6 months
up to 6 months
Percentage of sites with BOP
Time Frame: up to 6 months
up to 6 months
Percentage of sites with plaque accumulation
Time Frame: up to 6 months
up to 6 months
Serum vitamin D concentration
Time Frame: 1 month before treatment and up to 6 months
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
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
1 month before treatment, at baseline, at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Clinical Trials on Vitamin D3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings