- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02337257
Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans With Periodontal Disease (GumD)
Periodontal and Cardiometabolic Responses to Vitamin D Intervention in African Americans
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Tidig fas 1
Kontakter och platser
Studieorter
-
-
Georgia
-
Augusta, Georgia, Förenta staterna, 30912
- Rekrytering
- Georgia Prevention Institute
-
Kontakt:
- Anas Raed
- Telefonnummer: 706-721-1764
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- 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
Exclusion Criteria:
- Not meeting any of the above
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: cholecalciferol
Subjects will take 4000 IU per day for 30 days
|
subjects will receive one pill per day which contains 4000 IU/d for 16 weeks
Andra namn:
|
Placebo-jämförare: Placebo
Subjects will take placebo everyday for 30 days
|
subjects will receive placebo one pill per day for 16 weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Periodontal Disease Activity
Tidsram: 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
|
Baseline, 8 Weeks, 16 weeks.
|
Change in Cardiometabolic Risk Factors
Tidsram: 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)
|
Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Blood Myeloid Dendritic Cells
Tidsram: 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.
|
Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Yanbin Dong, PhD, Augusta University
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00001693
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