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

NCT02337257 | Unknown Early Phase 1

• 1 other identifier: Pro00001693
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Disease; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.

Secondary Outcomes (1)

• Change in Blood Myeloid Dendritic Cells

  Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.

Study Arms (2)

cholecalciferol

ACTIVE COMPARATOR

Subjects will take 4000 IU per day for 30 days

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Subjects will take placebo everyday for 30 days

Drug: Placebo

Interventions

Cholecalciferol DRUG

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

Also known as: Vitamin D3

cholecalciferol

Placebo DRUG

subjects will receive placebo one pill per day for 16 weeks

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Not meeting any of the above

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Georgia Prevention Institute

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Vitamin D Deficiency

Interventions

Cholecalciferol; Sugars

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Carbohydrates

Study Officials

• Yanbin Dong, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanbin Dong, PhD

CONTACT

706-721-5410; ydong@gru.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: January 13, 2015
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

US (1)