Trial record 3 of 7 for:    periodontal dendritic cells

Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans With Periodontal Disease (GumD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02337257
Recruitment Status : Unknown
Verified January 2015 by Yanbin Dong, Georgia Regents University.
Recruitment status was:  Recruiting
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Information provided by (Responsible Party):
Yanbin Dong, Georgia Regents University

Brief 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 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

Condition or disease Intervention/treatment Phase
Periodontal Disease Vitamin D Deficiency Drug: Cholecalciferol Drug: Placebo Early Phase 1

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:

  1. Group 1 who will receive placebo.
  2. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans
Study Start Date : April 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: cholecalciferol
Subjects will take 4000 IU per day for 30 days
Drug: Cholecalciferol
subjects will receive one pill per day which contains 4000 IU/d for 16 weeks
Other Name: Vitamin D3
Placebo Comparator: Placebo
Subjects will take placebo everyday for 30 days
Drug: Placebo
subjects will receive placebo one pill per day for 16 weeks
Other Name: sugar pill

Primary Outcome Measures :
  1. 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

  2. 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)

Secondary Outcome Measures :
  1. Change in Blood Myeloid Dendritic Cells [ Time Frame: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks. ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. You are African American
  2. You have generalized chronic moderate to severe gum disease (periodontitis)
  3. Your age is between 18-60 years.
  4. You are not taking any vitamin, mineral or herbal supplements
  5. If you are a female, you are not pregnant

Exclusion Criteria:

  • Not meeting any of the above

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02337257

Contact: Yanbin Dong, PhD 706-721-5410

United States, Georgia
Georgia Prevention Institute Recruiting
Augusta, Georgia, United States, 30912
Contact: Anas Raed    706-721-1764      
Principal Investigator: Yanbin Dong, MD, PhD         
Sponsors and Collaborators
Augusta University
Principal Investigator: Yanbin Dong, PhD Augusta University

Responsible Party: Yanbin Dong, Professor, Georgia Regents University Identifier: NCT02337257     History of Changes
Other Study ID Numbers: Pro00001693
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Periodontal Diseases
Vitamin D Deficiency
Gingival Diseases
Deficiency Diseases
Nutrition Disorders
Mouth Diseases
Stomatognathic Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents