CompletedNCT03044886Updated Feb 18, 2019Results posted

Effects of Vitamin D on Moderate to Severe Periodontitis

An interventional study of vitamin D in Chronic Peritonitis, sponsored by Beijing Chao Yang Hospital. Completed. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-02-18.

Sponsored by Beijing Chao Yang Hospital · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 360
Allocation: Randomized
Ages: 30 Years to 70 Years
Sex: All

Study 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.

Read the 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 studied

Chronic Peritonitis

Browse trials for

Keywords

Vitamin D

In context

Peritonitis

185 studies on the registry are indexed under Peritonitis; 25 are open to participants now.

This study's enrollment of 360 is above the median of 95 across 118 interventional studies indexed under Peritonitis.

Browse Peritonitis studies →

Lead sponsor

Beijing Chao Yang Hospital is the lead sponsor of 135 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 30 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Double (Participant, Care provider)
Enrollment: 360 participants (actual)

Study arms

Experimental
2000IU/day
Subjects took 2000IU vitamin D per day
Dietary Supplement: vitamin D
Experimental
1000IU/day
Subjects took 1000IU vitamin D per day
Dietary Supplement: vitamin D
Placebo comparator
Placebo
Subjects took placebo
Dietary Supplement: vitamin D

Interventions

Dietary supplementvitamin D
Subjects took vitamin D or placebo

What researchers measure

Primary outcomes

Attachment Loss (AL)
Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.
Time frame: at baseline
Attachment Loss (AL)
Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.
Time frame: 3 months after periodontal treatment
Attachment Loss (AL)
Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects
Time frame: 6 months after periodontal treatment

Secondary outcomes

Probing Depth (PD)
Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.
Time frame: at baseline
Probing Depth (PD)
Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.
Time frame: 3 months after periodontal treatment
Probing Depth (PD)
Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.
Time frame: 6 months after periodontal treatment
Alveolar Crest Height (ACH)
Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.
Time frame: at baseline
Alveolar Crest Height (ACH)
Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.
Time frame: 3 months after periodontal treatment
Alveolar Crest Height (ACH)
Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.
Time frame: 6 months after periodontal treatment
Bleeding Index (BI)
Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome.
Time frame: at baseline
Bleeding Index (BI)
Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome.
Time frame: 3 months after periodontal treatment
Bleeding Index (BI)
Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome.
Time frame: 6 months after periodontal treatment

Results

Posted Feb 18, 2019

Limitations and caveats

The observation time was short. Mechanical periodontal therapy might be too close in time to the vitamin D treatment. Did not adjust for possible confounding factors (e.g., dietary vitamin D) . The study was performed at one single center.

Participant flow

Participant flow — Overall Study
Milestone	2000IU/Day	1000IU/Day	Placebo
Started	120	120	120
Completed	105	110	108
Not completed	15	10	12
Withdrew: Lost to follow-up	15	10	12

Outcome measures

PrimaryAttachment Loss (AL)

Examination of AL was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.

Time frame:: at baseline
Reported as:: Mean · mm

Attachment Loss (AL)
mm	2000IU/Day	1000IU/Day	Placebo
Attachment Loss (AL)	4.7 ± 1.1	4.8 ± 0.9	4.8 ± 0.9

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.576

PrimaryAttachment Loss (AL)

Time frame:: 3 months after periodontal treatment
Reported as:: Mean · mm

Attachment Loss (AL)
mm	2000IU/Day	1000IU/Day	Placebo
Attachment Loss (AL)	3.5 ± 0.7	3.6 ± 0.7	3.6 ± 0.6

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.489

PrimaryAttachment Loss (AL)

Time frame:: 6 months after periodontal treatment
Reported as:: Mean · mm

Attachment Loss (AL)
mm	2000IU/Day	1000IU/Day	Placebo
Attachment Loss (AL)	3.4 ± 0.6	3.3 ± 0.6	3.3 ± 0.7

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.042
2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.041

SecondaryProbing Depth (PD)

Examination of PD was performed with Williams probe, included six sites of each tooth: mesial buccal, buccal, distal buccal, mesial lingual, lingual and distal lingual. The outcome was the mean value of all the sites of all subjects.

Time frame:: at baseline
Reported as:: Mean · mm

Probing Depth (PD)
mm	2000IU/Day	1000IU/Day	Placebo
Probing Depth (PD)	3.6 ± 0.8	3.7 ± 0.8	3.6 ± 0.7

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANCOVA · p = 0.710

SecondaryProbing Depth (PD)

Time frame:: 3 months after periodontal treatment
Reported as:: Mean · mm

Probing Depth (PD)
mm	2000IU/Day	1000IU/Day	Placebo
Probing Depth (PD)	2.5 ± 0.5	2.6 ± 0.4	2.6 ± 0.5

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.340

SecondaryProbing Depth (PD)

Time frame:: 6 months after periodontal treatment
Reported as:: Mean · mm

Probing Depth (PD)
mm	2000IU/Day	1000IU/Day	Placebo
Probing Depth (PD)	2.4 ± 0.5	2.5 ± 0.4	2.5 ± 0.4

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.048
2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.038

SecondaryAlveolar Crest Height (ACH)

Panoramic radiographs were taken to evaluate alveolar crest height (ACH) with measuring software (i-Dixel, One Volume Viewer, version 6.00, J. MORITA MFG. CORP. Japan). The alveolar crest height is defined as the mean of the two-dimensional vertical distance between mesial and distal alveolar crest to apical point.

Time frame:: at baseline
Reported as:: Mean · mm

Alveolar Crest Height (ACH)
mm	2000IU/Day	1000IU/Day	Placebo
Alveolar Crest Height (ACH)	7.7 ± 2.3	7.7 ± 2.2	7.8 ± 2.4

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.521

SecondaryAlveolar Crest Height (ACH)

Time frame:: 3 months after periodontal treatment
Reported as:: Mean · mm

Alveolar Crest Height (ACH)
mm	2000IU/Day	1000IU/Day	Placebo
Alveolar Crest Height (ACH)	7.7 ± 2.1	7.6 ± 2.3	7.7 ± 2.1

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.742

SecondaryAlveolar Crest Height (ACH)

Time frame:: 6 months after periodontal treatment
Reported as:: Mean · mm

Alveolar Crest Height (ACH)
mm	2000IU/Day	1000IU/Day	Placebo
Alveolar Crest Height (ACH)	7.7 ± 2.3	7.7 ± 2.2	7.7 ± 2.0

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = <0.05
2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.073

SecondaryBleeding Index (BI)

Examination of BI was performed with Williams probe, explored under the gingival margin about 1mm, and bleeding was observed after 30 seconds. BI was scored on a 0-5 scale, higher scores mean a worse outcome.

Time frame:: at baseline
Reported as:: Mean · score on a scale

Bleeding Index (BI)
score on a scale	2000IU/Day	1000IU/Day	Placebo
Bleeding Index (BI)	3.5 ± 1.1	3.2 ± 1.3	3.8 ± 1.2

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.348

SecondaryBleeding Index (BI)

Time frame:: 3 months after periodontal treatment
Reported as:: Mean · score on a scale

Bleeding Index (BI)
score on a scale	2000IU/Day	1000IU/Day	Placebo
Bleeding Index (BI)	1.5 ± 0.8	1.7 ± 0.6	1.6 ± 0.8

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.685

SecondaryBleeding Index (BI)

Time frame:: 6 months after periodontal treatment
Reported as:: Mean · score on a scale

Bleeding Index (BI)
score on a scale	2000IU/Day	1000IU/Day	Placebo
Bleeding Index (BI)	0.9 ± 0.3	1.2 ± 0.7	1.1 ± 0.6

Statistical analysis

2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.075
2000IU/Day vs 1000IU/Day vs Placebo · ANOVA · p = 0.083

Adverse events

Collected over Through study completion, an average of 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
2000IU/Day	0/120 (0%)	0/120 (0%)	0/120 (0%)
1000IU/Day	0/120 (0%)	0/120 (0%)	0/120 (0%)
Placebo	0/120 (0%)	0/120 (0%)	0/120 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	2000IU/Day	1000IU/Day	Placebo	Total
<=18 years	0	0	0	0
Between 18 and 65 years	103	110	107	320
>=65 years	17	10	13	40

Age, Continuous
Age, Continuous(years)	2000IU/Day	1000IU/Day	Placebo	Total
Mean	49 ± 5.4	51 ± 6.3	53 ± 5.2	51 ± 5.3

Sex: Female, Male
Sex: Female, Male(Participants)	2000IU/Day	1000IU/Day	Placebo	Total
Female	59	62	57	178
Male	61	58	63	182

Region of Enrollment
Region of Enrollment(participants)	2000IU/Day	1000IU/Day	Placebo	Total
China	120	120	120	360

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03044886
Lead sponsor: Beijing Chao Yang Hospital
Responsible party: Zuo Min Wang (Dean of Stomatology Department, Beijing Chao-Yang Hospital, Beijing Chao Yang Hospital) — Principal investigator
First posted: Feb 7, 2017
Start date: Jan 2013
Primary completion: Dec 2016
Completion: Dec 2016
Results posted: Feb 18, 2019
Last update: Feb 18, 2019

Study contacts

Zuomin Wang, Doctor

principal investigator · Dean of Stomatology Department

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peritonitis→

Other studies from this sponsor

Beijing Chao Yang Hospital

Start the discussion

Effects of Vitamin D on Moderate to Severe Periodontitis

Study summary

Conditions studied

Browse trials for

Keywords

In context

Peritonitis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Individual participant data

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria