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Dose-dependent Anti-inflammatory Effects of Vitamin D in a Human Gingivitis Model

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ClinicalTrials.gov Identifier: NCT00779909
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : October 2, 2017
Last Update Posted : October 2, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Boston University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Gingivitis
Interventions: Drug: vitamin D3
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
102 potential participants were screened for study eligibility, 61 met various exclusions criteria, and 41 were found to be eligible for randomization. Of the 41 eligible subjects 35 were randomized into the trial. The 6 not randomized were either lost to follow-up or they lost interest and withdrew their consent for further involvement.

Reporting Groups
  Description
1- Placebo placebo oral supplementation once per day for 12 weeks
2- Vitamin D3, 500 IU vitamin D3 500 IU oral supplementation once per day for 12 weeks
3- Vitamin D3 2500 IU vitamin D3 2500 IU oral supplementation once per day for 12 weeks
4- Vitamin D3 5000 IU vitamin D3 5000 IU oral supplementation once per day for 12 weeks

Participant Flow:   Overall Study
    1- Placebo   2- Vitamin D3, 500 IU   3- Vitamin D3 2500 IU   4- Vitamin D3 5000 IU
STARTED   10   9   8   8 
COMPLETED   9   8   8   7 
NOT COMPLETED   1   1   0   1 
Lost to Follow-up                1                0                0                1 
Withdrawal by Subject                0                1                0                0 



  Baseline Characteristics


  Outcome Measures

1.  Primary:   Proportion of Sites That Bleed on Probing   [ Time Frame: end of 4 week experimental gingivitis phase ]

2.  Primary:   Mandibular Modified Gingival Index (MGI) Score   [ Time Frame: week 8 and week 12 ]

3.  Primary:   Maxillary Modified Gingival Index (MGI) Score   [ Time Frame: week 8 and week 12 ]

4.  Secondary:   Mandibular Plaque Index (PI) Score   [ Time Frame: week 8 and week 12 ]

5.  Secondary:   Maxillary Plaque Index (PI) Score   [ Time Frame: week 8 and week 12 ]

6.  Secondary:   Gingival Crevicular Fluid (GCF) Volume   [ Time Frame: week 8 and week 12 ]

7.  Secondary:   Gingival Crevicular Fluid (GCF) Concentrations of TNF-alpha, IL1-beta, IL-2, IL-12   [ Time Frame: week 8 and week 12 ]

8.  Secondary:   Serum Calcium   [ Time Frame: week 7, week 12 ]

9.  Secondary:   Urinary Calcium/Creatinine Ratio   [ Time Frame: week 4, week 7, week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were recruitment delays due to the potential seasonal impact on vitamin D levels from the sun and the research center was relocated. Both resulted in lower enrollment during the funded time frame than originally projected.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Raul I Garcia, DMD
Organization: Boston University School of Dental Medicine
phone: 617-638-6385
e-mail: rig@bu.edu



Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT00779909     History of Changes
Other Study ID Numbers: H-26461
R21AT003714-01 ( U.S. NIH Grant/Contract )
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: May 26, 2017
Results First Posted: October 2, 2017
Last Update Posted: October 2, 2017