Effects of Vitamin D on Moderate to Severe Periodontitis

Capital Medical University

Status: Completed

Conditions: Chronic Peritonitis

Treatments: Dietary Supplement: vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03044886

BeijingCYH1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 360 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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360 participants in 3 patient groups, including a placebo group

2000IU/day

Experimental group

Description:

Subjects took 2000IU vitamin D per day

Treatment:

Dietary Supplement: vitamin D

1000IU/day

Experimental group

Description:

Subjects took 1000IU vitamin D per day

Treatment:

Dietary Supplement: vitamin D

Placebo

Placebo Comparator group

Description:

Subjects took placebo

Treatment:

Dietary Supplement: vitamin D