- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
-
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Georgia
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Augusta, Georgia, Forente stater, 30912
- Rekruttering
- Georgia Prevention Institute
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Ta kontakt med:
- Anas Raed
- Telefonnummer: 706-721-1764
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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
Andre navn:
|
Placebo komparator: Placebo
Subjects will take placebo everyday for 30 days
|
subjects will receive placebo one pill per day for 16 weeks
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Periodontal Disease Activity
Tidsramme: 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
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Baseline, 8 Weeks, 16 weeks.
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Change in Cardiometabolic Risk Factors
Tidsramme: 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)
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Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change in Blood Myeloid Dendritic Cells
Tidsramme: 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.
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Baseline, 8 Weeks, 24hrs post-Scaling and Root planing, 16 weeks.
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Yanbin Dong, PhD, Augusta University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Ernæringsforstyrrelser
- Stomatognatiske sykdommer
- Munnsykdommer
- Avitaminose
- Mangelsykdommer
- Underernæring
- Vitamin D-mangel
- Periodontale sykdommer
- Fysiologiske effekter av legemidler
- Mikronæringsstoffer
- Vitaminer
- Bone Density Conservation Agents
- Kalsiumregulerende hormoner og midler
- Vitamin d
- Kolekalsiferol
Andre studie-ID-numre
- Pro00001693
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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