Effects of Vitamin D on Moderate to Severe Periodontitis

NCT ID: NCT03044886

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-12-31

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).

Conditions

Chronic Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

2000IU/day

Subjects took 2000IU vitamin D per day

Group Type: EXPERIMENTAL

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Subjects took vitamin D or placebo

1000IU/day

Subjects took 1000IU vitamin D per day

Group Type: EXPERIMENTAL

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Subjects took vitamin D or placebo

Placebo

Subjects took placebo

Group Type: PLACEBO_COMPARATOR

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Subjects took vitamin D or placebo

Interventions

vitamin D

Subjects took vitamin D or placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zuo Min Wang

Dean of Stomatology Department, Beijing Chao-Yang Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zuomin Wang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Dean of Stomatology Department

Other Identifiers

BeijingCYH1

Identifier Type: -

Identifier Source: org_study_id