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Trial record 3 of 7 for:    periodontal dendritic cells

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Augusta University
Sponsor:
Information provided by (Responsible Party):
Yanbin Dong, Georgia Regents University
ClinicalTrials.gov Identifier:
NCT02337257
First received: December 11, 2014
Last updated: January 8, 2015
Last verified: January 2015
  Purpose
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 Intervention Phase
Periodontal Disease
Vitamin D Deficiency
Drug: Cholecalciferol
Drug: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans

Resource links provided by NLM:


Further study details as provided by Augusta University:

Primary Outcome Measures:
  • Change in Periodontal Disease Activity [ Time Frame: Baseline, 8 Weeks, 16 weeks. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Cardiometabolic risk factors will be measured by pulse wave velocity, central and peripheral blood pressure and glycated hemoglobin (A1C)


Secondary Outcome Measures:
  • Change in Blood Myeloid Dendritic Cells [ Time Frame: Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02337257

Contacts
Contact: Yanbin Dong, PhD 706-721-5410 ydong@gru.edu

Locations
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
Investigators
Principal Investigator: Yanbin Dong, PhD Augusta University
  More Information

Responsible Party: Yanbin Dong, Professor, Georgia Regents University
ClinicalTrials.gov Identifier: NCT02337257     History of Changes
Other Study ID Numbers: Pro00001693 
Study First Received: December 11, 2014
Last Updated: January 8, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 07, 2016