Clinical trial NCT03044886: Effects of Vitamin D on Moderate to Severe Periodontitis
Official title: Effects of Vitamin D on Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Peritonitis
Keywords: Vitamin D
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 360
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The object of the study was to evaluate the direct effect of high dose vitamin D supplementation on chronic periodontitis, and suggest the recommended dose for clinic use.

Detailed description: Periodontitis is a chronic inflammatory disease characterized by periodontal tissues inflammation and alveolar bone loss. Vitamin D is involved in stimulating osteoblasts to enable normal bone growth and preservation, also the regulation of cellular proliferation, differentiation, innate immune response and anti-inflammatory effect.Previous studies have reported the association of vitamin D levels and gingivitis and periodontitis. This study was designed as a randomized controlled trial to evaluate the effect of vitamin D supplementation on chronic periodontitis.

The study was divided into two phases. Recruitment including baseline clinical measurements was obtained and standard periodontal treatments were performed in Phase One. The randomization and intervention of vitamin D were performed in Phase Two. The 323 subjects were randomly divided into 3 groups (n=105,110,108) to receive a supplement kit containing 90 capsules of 2000 IU vitamin D, 1000 IU vitamin D, or placebo capsule for 3 months. After intervention, all the subjects were followed up after 3 months and received standard periodontal examination, including attachment loss (AL), probing depth (PD), bleeding index (BI), and panoramic radiographs were taken to evaluate alveolar crest height (ACH).

Eligibility criteria: Inclusion Criteria:

1. Age from 30 years old to 70 years old
2. More than 20 teeth remaining in the mouth
3. Clinical diagnosis of moderate to severe periodontitis
4. Not receiving periodontal treatment within 6 months
5. Not taking antibiotic drugs within 3 months.

Exclusion Criteria:

1. Diabetes, thyroid and parathyroid endocrine associated diseases
2. Severe systemic diseases, such as cancer
3. Taking vitamin D and / or calcium drugs during observation
4. Taking aspirin, non-steroidal anti-inflammatory drugs, and steroids
5. Pregnant or prepare to pregnant within one year
6. Have been suffering from hypercalcemia, malabsorption syndrome.

Primary outcomes:
measure: Attachment Loss (AL)
timeFrame: at baseline
measure: Attachment Loss (AL)
timeFrame: 3 months after periodontal treatment
measure: Attachment Loss (AL)
timeFrame: 6 months after periodontal treatment
Secondary outcomes:
measure: Probing Depth (PD)
timeFrame: at baseline
measure: Probing Depth (PD)
timeFrame: 3 months after periodontal treatment
measure: Probing Depth (PD)
timeFrame: 6 months after periodontal treatment
measure: Alveolar Crest Height (ACH)
timeFrame: at baseline
measure: Alveolar Crest Height (ACH)
timeFrame: 3 months after periodontal treatment
measure: Alveolar Crest Height (ACH)
timeFrame: 6 months after periodontal treatment
measure: Bleeding Index (BI)
timeFrame: at baseline
measure: Bleeding Index (BI)
timeFrame: 3 months after periodontal treatment
measure: Bleeding Index (BI)
timeFrame: 6 months after periodontal treatment
Other outcomes:
Locations:
Study officials:
affiliation: Dean of Stomatology Department
name: Zuomin Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: