Vitamin D DeficiencyNCT04066842
Vitamin D in Systemic Sclerosis Patients With Periodontitis
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 Systemic Sclerosis (SSc) and coronary heart disease (CHD). Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Observation
- How many people
- 168 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2015to 30 May 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study
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 In Systemic Sclerosis Patients With Periodontitis: A Possible Role In Cardiovascular Disease Risk Progression?
Vitamin D has been considered to possess anti-inflammatory and antimicrobial activity which may be a link for the known interaction of Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, 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 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study.
- Conditions
- Vitamin D Deficiency
- Being tested
- Observation
- 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.
ObservationOther
Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease
| Study group | Role | What they receive |
|---|---|---|
| 1 - Controls | Control Healthy controls Receives: Other: Observation | |
| 2 - SSc | SSc Systemic Sclerosis Receives: Other: Observation | |
| 3 - Cardiovascular | Cardiovascular Cardiovascular disease Receives: Other: Observation | |
| 4 - SSc+Periodontitis | SSc+ Periodontitis Systemic Sclerosis with Periodontitis Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin D levels
Evaluation of serum Vitamin D levels
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 posted26 Aug 2019
- Study start1 Nov 2015
- Primary completion15 May 2019
- Study completion30 May 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 168 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 Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066842
- Sponsor's protocol ID
- 10-918
- Status last verified
- Aug 2019
- First submitted
- 22 Aug 2019
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Vitamin D In Systemic Sclerosis Patients With Periodontitis: A Possible Role In Cardiovascular Disease Risk Progression?
- ClinicalTrials.gov ID
- NCT04066842
- Acronym / sponsor ID
- 10-918
- Conditions
- Vitamin D Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University of MessinaUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 26 Aug 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 Systemic Sclerosis (SSc) and coronary heart disease (CHD). This study investigated the association between serum vitamin D levels and SSc and periodontitis in patients with SSc, 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 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 - Controls | – | Other: ObservationControl Healthy controls |
| 2 - SSc | – | Other: ObservationSSc Systemic Sclerosis |
| 3 - Cardiovascular | – | Other: ObservationCardiovascular Cardiovascular disease |
| 4 - SSc+Periodontitis | – | Other: ObservationSSc+ Periodontitis Systemic Sclerosis with Periodontitis |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 42 patients with SSc, 43 patients with CHD, 41 patients with both SSc and CP, and 42 healthy patients were enrolled in the present study
Key inclusion criteria (5 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 |
|---|---|---|
| ObservationEvaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease | Other | 1 - Controls, 2 - SSc, 3 - Cardiovascular, 4 - SSc+Periodontitis |
Primary outcome
Vitamin D levels
Time frame: 1 year
Evaluation of serum Vitamin D levels
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 26 Aug 2019.
- Individual participant dataSharing planned: Yes. all collected IPD, 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 Catania
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 5 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 26 Aug 2019. 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?
Vitamin D levels (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 26 Aug 2019.