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

NCT03162406 | Unknown

• 1 other identifier: 2017/06JAN/013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Chronic Periodontitis; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

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

  up to 6 months

Secondary Outcomes (13)

• 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

Study Arms (2)

Vitamin D

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Oral supplementation 25000 IU once per week for 6 months

Also known as: Cholecalciferol

Vitamin D

Placebo DIETARY_SUPPLEMENT

Oral supplementation once per week for 6 months

Also known as: Clear, slightly yellow, oily liquid with an orange odour

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 32992785 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Jérôme Lasserre, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

• Etienne Cavalier, PhD

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

  STUDY CHAIR

Central Study Contacts

Jérôme Lasserre, PhD

CONTACT

00322764; jerome.lasserre@uclouvain.be

Marina Peric, DMD

CONTACT

00322764; marina.peric@student.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: May 18, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

BE (1)