Periodontal DiseaseEarly Phase 1GumDNCT02337257
Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans With Periodontal Disease
A Early Phase 1 study testing Cholecalciferol in people with Periodontal Disease and Vitamin D Deficiency, run by Augusta University at 1 site in United States.
Trial summary
Poor vitamin D status is very common in African Americans. Periodontitis (gum disease) are shown to be related to theincreased risk of cardiometabolic diseases. Vitamin D is freely available and cheap supplement that has shown beneficialeffect in the immune system regulation and maintenance of the cardiovascular… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2015
- Phase
- Early Phase 1
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- You are African American
- You have generalized chronic moderate to severe gum disease (periodontitis)
- Your age is between 18-60 years.
- You are not taking any vitamin, mineral or herbal supplements
- If you are a female, you are not pregnant
Who cannot join
- Not meeting any of the above
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Georgia Prevention Institute
Augusta, Georgia, 30912
Anas Raed, 706-721-1764
Yanbin Dong, MD, PhD
About this study
Official title: Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans
Poor vitamin D status is very common in African Americans. Periodontitis (gum disease) are shown to be related to theincreased risk of cardiometabolic diseases. Vitamin D is freely available and cheap supplement that has shown beneficialeffect in the immune system regulation and maintenance of the cardiovascular health. In this study The investigators hypothesize thatvitamin D supplementation for 16 weeks in African Americans with periodontitis will result in clinical improvement in theirgum health as well as their cardiometabolic risk profile
Read the detailed description
This is a double-blind placebo-controlled randomized clinical trial of vitamin D supplementation.
The eligible subjects will be assigned to a specific group by random assignment in one of the following two groups:
- Group 1 who will receive placebo.
- Group 2 who will receive 4,000 IU vitamin D.
Both groups will receive either the placebo pills or vitamin D supplementation everyday for 16 weeks. At visit 1: a fasting morning urine sample will be collected. Height, weight, hip and waist circumferences will be measured. Automatic and manual blood pressures will be measured in sitting position. Approximately 80 ml of venous blood will be collected. Arterial stiffness will be assessed non-invasively by the SphygmoCor device. This device also measures the central (aortic) BP and simultaneously measures pulse wave velocity (PWV). A bottle of 30 capsules containing either vitamin D or placebo will be given to the subjects and will be asked to take one capsule every day for next month till the second visit. A questionnaire to assess the dietary habits, tobacco use, sun exposure, physical activity, socio-economic status and family health history will be given to the subject. At the dental clinic, full mouth clinical measurements (periodontal probing) will be performed. A plaque sample will be taken and a gum biopsy will be taken to examine the dendritic cells. Also, a saliva sample will be collected.
At visit 2: one month later, the supplements will be replenished, compliance will be assessed, and subjects will be examined for any potential side effects.
At visit 3: at 8-week follow up, anthropometric measures, blood samples as well as BP and PWV will be measured and the subject will be assessed for clinical improvement in the periodontitis. All the subjects, irrespective of their group assignment will undergo intensive scaling and root planing (S\&RP). The supplements will be replenished, compliance will be assessed, and subjects will be examined for any potential side effects.
Another fasting blood draw, BP measurement and PWV will be performed approximately 24 hours after the S\&RP. Also, the investigators will collect saliva sample during this visit.
At visit 4: at 12-week follow up, the procedure in this visit are similar to the visit 2.
At visit 5: at 16-week follow up, a post-test evaluation of vitamin D status, cardiovascular phenotypes and periodontitis will be done at the end of the study.
- Conditions
- Periodontal Disease, Vitamin D Deficiency
- Being tested
- Cholecalciferol, Placebo
- Medical subject headings
- Periodontal Diseases, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
subjects will receive one pill per day which contains 4000 IU/d for 16 weeks
PlaceboDrug
Also called sugar pill
subjects will receive placebo one pill per day for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| cholecalciferol | Active comparator | Subjects will take 4000 IU per day for 30 days Receives: Drug: Cholecalciferol |
| Placebo | Placebo comparator | Subjects will take placebo everyday for 30 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Periodontal Disease Activity
Periodontal disease activity will be measured using standard periodontal disease measures of pocket depth, blood on probing, periodontal inflamed surface area, plaque scores, bone loss, and clinical attachment loss
Measured: Baseline, 8 Weeks, 16 weeks.
Change in Cardiometabolic Risk Factors
Cardiometabolic risk factors will be measured by pulse wave velocity, central and peripheral blood pressure and glycated hemoglobin (A1C)
Measured: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
Secondary outcomes (1)
Change in Blood Myeloid Dendritic Cells
Relative gene expression (transcripts) in blood myeloid dendritic cells (mDCs) by polymerase chain reaction (PCR) array, validated by protein, of markers of DC homeostasis and atherogenesis.
Measured: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startApr 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbin Dong, Augusta University
- Investigators
- Yanbin Dong, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337257
- Sponsor's protocol ID
- Pro00001693
- Acronym
- GumD
- Status last verified
- Jan 2015
- First submitted
- 11 Dec 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans
- ClinicalTrials.gov ID
- NCT02337257
- Acronym / sponsor ID
- GumD / Pro00001693
- Conditions
- Periodontal Disease, Vitamin D Deficiency
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 Jan 2015 (estimated)
- 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.
Poor vitamin D status is very common in African Americans. Periodontitis (gum disease) are shown to be related to theincreased risk of cardiometabolic diseases. Vitamin D is freely available and cheap supplement that has shown beneficialeffect in the immune system regulation and maintenance of the cardiovascular health. In this study The investigators hypothesize thatvitamin D supplementation for 16 weeks in African Americans with periodontitis will result in clinical improvement in theirgum health as well as their cardiometabolic risk profile
Detailed description
This is a double-blind placebo-controlled randomized clinical trial of vitamin D supplementation.
The eligible subjects will be assigned to a specific group by random assignment in one of the following two groups:
- Group 1 who will receive placebo.
- Group 2 who will receive 4,000 IU vitamin D.
Both groups will receive either the placebo pills or vitamin D supplementation everyday for 16 weeks. At visit 1: a fasting morning urine sample will be collected. Height, weight, hip and waist circumferences will be measured. Automatic and manual blood pressures will be measured in sitting position. Approximately 80 ml of venous blood will be collected. Arterial stiffness will be assessed non-invasively by the SphygmoCor device. This device also measures the central (aortic) BP and simultaneously measures pulse wave velocity (PWV). A bottle of 30 capsules containing either vitamin D or placebo will be given to the subjects and will be asked to take one capsule every day for next month till the second visit. A questionnaire to assess the dietary habits, tobacco use, sun exposure, physical activity, socio-economic status and family health history will be given to the subject. At the dental clinic, full mouth clinical measurements (periodontal probing) will be performed. A plaque sample will be taken and a gum biopsy will be taken to examine the dendritic cells. Also, a saliva sample will be collected.
At visit 2: one month later, the supplements will be replenished, compliance will be assessed, and subjects will be examined for any potential side effects.
At visit 3: at 8-week follow up, anthropometric measures, blood samples as well as BP and PWV will be measured and the subject will be assessed for clinical improvement in the periodontitis. All the subjects, irrespective of their group assignment will undergo intensive scaling and root planing (S\&RP). The supplements will be replenished, compliance will be assessed, and subjects will be examined for any potential side effects.
Another fasting blood draw, BP measurement and PWV will be performed approximately 24 hours after the S\&RP. Also, the investigators will collect saliva sample during this visit.
At visit 4: at 12-week follow up, the procedure in this visit are similar to the visit 2.
At visit 5: at 16-week follow up, a post-test evaluation of vitamin D status, cardiovascular phenotypes and periodontitis will be done at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cholecalciferol | Active comparator | Drug: CholecalciferolSubjects will take 4000 IU per day for 30 days |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will take placebo everyday for 30 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- You are African American
- You have generalized chronic moderate to severe gum disease (periodontitis)
- Your age is between 18-60 years.
- You are not taking any vitamin, mineral or herbal supplements
- If you are a female, you are not pregnant
Key exclusion criteria (1 listed)
- Not meeting any of the above
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D3subjects will receive one pill per day which contains 4000 IU/d for 16 weeks | Drug | cholecalciferol |
| PlaceboAlso: sugar pillsubjects will receive placebo one pill per day for 16 weeks | Drug | Placebo |
Primary outcome
Change in Periodontal Disease Activity
Time frame: Baseline, 8 Weeks, 16 weeks.
Periodontal disease activity will be measured using standard periodontal disease measures of pocket depth, blood on probing, periodontal inflamed surface area, plaque scores, bone loss, and clinical attachment loss
Change in Cardiometabolic Risk Factors
Time frame: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
Cardiometabolic risk factors will be measured by pulse wave velocity, central and peripheral blood pressure and glycated hemoglobin (A1C)
1 secondary outcome
Change in Blood Myeloid Dendritic Cells
Time frame: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
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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.
Yanbin Dong, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cholecalciferol in people with Periodontal Disease and Vitamin D Deficiency, run by Augusta University at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Jan 2015. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanbin Dong, PhD (706-721-5410, ydong@gru.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Periodontal Disease Activity (time frame: Baseline, 8 Weeks, 16 weeks.). The study lists 2 primary outcomes in all. 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 13 Jan 2015.