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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03162406
Recruitment Status : Unknown
Verified May 2017 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was:  Recruiting
First Posted : May 22, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Generalized Chronic Periodontitis Vitamin D Deficiency Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Vitamin D Supplementation During a Non-surgical Treatment of Generalized Chronic Periodontitis: A Randomized Double-blinded Placebo Controlled Clinical Trial
Actual Study Start Date : May 18, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: 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 Name: Clear, slightly yellow, oily liquid with an orange odour




Primary Outcome Measures :
  1. Percentage of subjects reaching ≤ 4 periodontal sites with PPD ≥ 5 mm [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Number of sites with PPD ≥ 5 mm [ Time Frame: up to 6 months ]
  2. Number of sites with PPD ≥ 6 mm [ Time Frame: up to 6 months ]
  3. Number of sites with PPD ≥ 7 mm [ Time Frame: up to 6 months ]
  4. Reduction in the number of sites with PPD ≥ 5 mm [ Time Frame: up to 6 months ]
  5. Reduction in the number of sites with PPD ≥ 6 mm [ Time Frame: up to 6 months ]
  6. Reduction in the number of sites with PPD ≥ 7 mm [ Time Frame: up to 6 months ]
  7. Full-mouth PPD [ Time Frame: up to 6 months ]
  8. Full-mouth CAL [ Time Frame: up to 6 months ]
  9. Percentage of sites with BOP [ Time Frame: up to 6 months ]
  10. Percentage of sites with plaque accumulation [ Time Frame: up to 6 months ]
  11. Serum vitamin D concentration [ Time Frame: 1 month before treatment and up to 6 months ]
  12. Serum high-sensitivity C-reactive Protein (hs-CRP) [ Time Frame: 1 month before treatment, at baseline, at 6 months ]
  13. Serum high-density lipoprotein (HDL) cholesterol [ Time Frame: 1 month before treatment, at baseline, at 6 months ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162406


Contacts
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Contact: Jérôme Lasserre, PhD 00322764 ext 5719 jerome.lasserre@uclouvain.be
Contact: Marina Peric, DMD 00322764 ext 5719 marina.peric@student.uclouvain.be

Locations
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Belgium
Cliniques universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Jérôme Lasserre, PhD    00322764 ext 5719    jerome.lasserre@uclouvain.be   
Contact: Marina Peric, PhD    00322764 ext 5719    marina.peric@uclouvain.be   
Sub-Investigator: Selena Toma, PhD         
Sub-Investigator: Dominique Maiter, MD, PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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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

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03162406     History of Changes
Other Study ID Numbers: 2017/06JAN/013
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It will be decided at the end of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Chronic Periodontitis
Periodontitis
Vitamin D Deficiency
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents