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

NCT ID: NCT02337257

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-12-31

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

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.

Conditions

Periodontal Disease; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

cholecalciferol

Subjects will take 4000 IU per day for 30 days

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

subjects will receive one pill per day which contains 4000 IU/d for 16 weeks

Placebo

Subjects will take placebo everyday for 30 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

subjects will receive placebo one pill per day for 16 weeks

Interventions

Cholecalciferol

subjects will receive one pill per day which contains 4000 IU/d for 16 weeks

Intervention Type: DRUG

Placebo

subjects will receive placebo one pill per day for 16 weeks

Intervention Type: DRUG

Other Intervention Names

Vitamin D3; sugar pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Yanbin Dong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanbin Dong, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Georgia Prevention Institute

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yanbin Dong, PhD

Role: CONTACT

ydong@gru.edu

706-721-5410

Facility Contacts

Anas Raed

Role: primary

706-721-1764

Other Identifiers

Pro00001693

Identifier Type: -

Identifier Source: org_study_id