Trial Outcomes & Findings for Effects of Vitamin D on Moderate to Severe Periodontitis (NCT NCT03044886)

NCT ID: NCT03044886

Last Updated: 2019-02-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 360 participants
• Primary outcome timeframe: at baseline
• Results posted on: 2019-02-18

Participant Flow

Participant milestones

Measure	2000IU/Day Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Overall Study STARTED	120	120	120
Overall Study COMPLETED	105	110	108
Overall Study NOT COMPLETED	15	10	12

Reasons for withdrawal

Measure	2000IU/Day Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Overall Study Lost to Follow-up	15	10	12

Baseline Characteristics

Effects of Vitamin D on Moderate to Severe Periodontitis

Baseline characteristics by cohort

Measure	2000IU/Day n=120 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=120 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=120 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo	Total n=360 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=93 Participants	110 Participants n=4 Participants	107 Participants n=27 Participants	320 Participants n=483 Participants
Age, Categorical >=65 years	17 Participants n=93 Participants	10 Participants n=4 Participants	13 Participants n=27 Participants	40 Participants n=483 Participants
Age, Continuous	49 years STANDARD_DEVIATION 5.4 • n=93 Participants	51 years STANDARD_DEVIATION 6.3 • n=4 Participants	53 years STANDARD_DEVIATION 5.2 • n=27 Participants	51 years STANDARD_DEVIATION 5.3 • n=483 Participants
Sex: Female, Male Female	59 Participants n=93 Participants	62 Participants n=4 Participants	57 Participants n=27 Participants	178 Participants n=483 Participants
Sex: Female, Male Male	61 Participants n=93 Participants	58 Participants n=4 Participants	63 Participants n=27 Participants	182 Participants n=483 Participants
Region of Enrollment China	120 participants n=93 Participants	120 participants n=4 Participants	120 participants n=27 Participants	360 participants n=483 Participants

PRIMARY outcome

Timeframe: at baseline

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Attachment Loss (AL)	4.7 mm Standard Deviation 1.1	4.8 mm Standard Deviation 0.9	4.8 mm Standard Deviation 0.9

PRIMARY outcome

Timeframe: 3 months after periodontal treatment

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Attachment Loss (AL)	3.5 mm Standard Deviation 0.7	3.6 mm Standard Deviation 0.7	3.6 mm Standard Deviation 0.6

PRIMARY outcome

Timeframe: 6 months after periodontal treatment

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

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Attachment Loss (AL)	3.4 mm Standard Deviation 0.6	3.3 mm Standard Deviation 0.6	3.3 mm Standard Deviation 0.7

SECONDARY outcome

Timeframe: at baseline

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Probing Depth (PD)	3.6 mm Standard Deviation 0.8	3.7 mm Standard Deviation 0.8	3.6 mm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 3 months after periodontal treatment

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Probing Depth (PD)	2.5 mm Standard Deviation 0.5	2.6 mm Standard Deviation 0.4	2.6 mm Standard Deviation 0.5

SECONDARY outcome

Timeframe: 6 months after periodontal treatment

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Probing Depth (PD)	2.4 mm Standard Deviation 0.5	2.5 mm Standard Deviation 0.4	2.5 mm Standard Deviation 0.4

SECONDARY outcome

Timeframe: at baseline

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Alveolar Crest Height (ACH)	7.7 mm Standard Deviation 2.3	7.7 mm Standard Deviation 2.2	7.8 mm Standard Deviation 2.4

SECONDARY outcome

Timeframe: 3 months after periodontal treatment

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Alveolar Crest Height (ACH)	7.7 mm Standard Deviation 2.1	7.6 mm Standard Deviation 2.3	7.7 mm Standard Deviation 2.1

SECONDARY outcome

Timeframe: 6 months after periodontal treatment

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Alveolar Crest Height (ACH)	7.7 mm Standard Deviation 2.3	7.7 mm Standard Deviation 2.2	7.7 mm Standard Deviation 2.0

SECONDARY outcome

Timeframe: at baseline

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Bleeding Index (BI)	3.5 score on a scale Standard Deviation 1.1	3.2 score on a scale Standard Deviation 1.3	3.8 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 3 months after periodontal treatment

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Bleeding Index (BI)	1.5 score on a scale Standard Deviation 0.8	1.7 score on a scale Standard Deviation 0.6	1.6 score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 6 months after periodontal treatment

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.

Outcome measures

Measure	2000IU/Day n=105 Participants Subjects took 2000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	1000IU/Day n=110 Participants Subjects took 1000IU vitamin D per day vitamin D: Subjects took vitamin D or placebo	Placebo n=108 Participants Subjects took placebo vitamin D: Subjects took vitamin D or placebo
Bleeding Index (BI)	0.9 score on a scale Standard Deviation 0.3	1.2 score on a scale Standard Deviation 0.7	1.1 score on a scale Standard Deviation 0.6

Adverse Events

2000IU/Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1000IU/Day

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Wang Zuomin

Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University

Phone: +86-010-85231492

Email: wzuomin@sina.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place