Vitamin D DeficiencyNCT03873935
Vitamin D in Periodontal and Cardiovascular Disease Progression
An observational study of Vitamin D Deficiency, run by University of Messina at 1 site in Italy.
Trial summary
Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Evaluation of periodontal status
- How many people
- 179 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2015to 5 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thus, for this study, at least of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will finally enrolled.
Who may be able to join
- Presence of at least twenty teeth
- CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
- Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- Presence of ≥40% sites with bleeding on probing (BOP)
Who cannot join
- Intake of contraceptives
- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- Status of pregnancy or lactation
- Previous history of excessive drinking
- Allergy to local anaesthetic
- Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression
Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.
Read the detailed description
Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.
- Conditions
- Vitamin D Deficiency
- Being tested
- Evaluation of periodontal status
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of periodontal statusOther
Clinical examination
| Study group | Role | What they receive |
|---|---|---|
| Control | Healthy subjects Receives: Other: Evaluation of periodontal status | |
| Periodontitis | Patients with periodontal disease Receives: Other: Evaluation of periodontal status | |
| Cardiovascular | Patients with cardiovascular disease Receives: Other: Evaluation of periodontal status | |
| Periodontitis+Cardiovascular | People with both cardiovascular and periodontitis Receives: Other: Evaluation of periodontal status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment level
Clinical Analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start2 Jan 2015
- Primary completion5 Jan 2018
- Study completion5 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Messina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gaetano Isola, DDS, PhD, University of Messina
- Investigators
- Gaetano Isola, Principal investigator, University of Messina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873935
- Sponsor's protocol ID
- #17-09
- Status last verified
- Dec 2022
- First submitted
- 9 Mar 2019
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vitamin D on Periodontal and Cardiovascular Diseases Progression
- ClinicalTrials.gov ID
- NCT03873935
- Acronym / sponsor ID
- #17-09
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 2 Jan 2015 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Feb 2019 (actual)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of periodontitis (CP) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and periodontitis in patients with CP and with CHD. Furthermore, the objective was to determine if periodontitis and CHD had an impact on serum vitamin D levels.
Detailed description
Using a cross-sectional design, a total of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will enrolled in the present study.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Evaluation of periodontal statusHealthy subjects |
| Periodontitis | – | Other: Evaluation of periodontal statusPatients with periodontal disease |
| Cardiovascular | – | Other: Evaluation of periodontal statusPatients with cardiovascular disease |
| Periodontitis+Cardiovascular | – | Other: Evaluation of periodontal statusPeople with both cardiovascular and periodontitis |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thus, for this study, at least of 39 patients with CP, 38 patients with CHD, 38 patients with both CP and CHD, and 37 healthy subjects will finally enrolled.
Key inclusion criteria (4 listed)
- Presence of at least twenty teeth
- CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
- Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
- Presence of ≥40% sites with bleeding on probing (BOP)
Key exclusion criteria (6 listed)
- Intake of contraceptives
- Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
- Status of pregnancy or lactation
- Previous history of excessive drinking
- Allergy to local anaesthetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of periodontal statusClinical examination | Other | Cardiovascular, Control, Periodontitis, Periodontitis+Cardiovascular |
Primary outcome
Clinical Attachment level
Time frame: 1 year
Clinical Analysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Isola principal investigator
University of Messina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin D Deficiency, run by University of Messina at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Attachment level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.