NCT03044886

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

February 18, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

January 17, 2017

Results QC Date

November 12, 2017

Last Update Submit

February 10, 2019

Conditions

Chronic Peritonitis

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    6 months after periodontal treatment

Secondary Outcomes (9)

  • Probing Depth (PD)

    at baseline

  • Probing Depth (PD)

    3 months after periodontal treatment

  • Probing Depth (PD)

    6 months after periodontal treatment

  • Alveolar Crest Height (ACH)

    at baseline

  • Alveolar Crest Height (ACH)

    3 months after periodontal treatment

  • +4 more secondary outcomes

Study Arms (3)

2000IU/day

EXPERIMENTAL

Subjects took 2000IU vitamin D per day

Dietary Supplement: vitamin D

1000IU/day

EXPERIMENTAL

Subjects took 1000IU vitamin D per day

Dietary Supplement: vitamin D

Placebo

PLACEBO COMPARATOR

Subjects took placebo

Dietary Supplement: vitamin D

Interventions

vitamin DDIETARY_SUPPLEMENT

Subjects took vitamin D or placebo

1000IU/day2000IU/dayPlacebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

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.

Results Point of Contact

Title
Dr. Wang Zuomin
Organization
Department of Stomatology, Beijing Chao-yang Hospital, Capital Medical University
wzuomin@sina.cn
+86-010-85231492

Study Officials

  • Zuomin Wang, Doctor

    Dean of Stomatology Department

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dean of Stomatology Department, Beijing Chao-Yang Hospital

Study Record Dates

First Submitted

January 17, 2017

First Posted

February 7, 2017

Study Start

January 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 18, 2019

Results First Posted

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share