- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01570309
Vitamin D Repletion in Coronary Artery Disease
The Effects of Vitamin D Repletion on Endothelial Function and Inflammation in Patients With Coronary Artery Disease
Vitamin D (Vit D) status is an emerging risk marker of great interest in cardiovascular disease (CVD). Lower serum levels of Vit D are associated with both cardiac risk factors and prevalent cardiovascular disease. Vit D insufficiency remains very prevalent in free living populations in the United States especially in urban, and multi-ethnic low income Northern cities.To date, prospective randomized trials using Vit D supplementation to modify CVD risk and evaluate outcomes have not been performed.
The investigators propose a double-blind, randomized wait-list control trial in subjects with Coronary Artery Disease (CAD) and Vit D deficiency with two specific aims. Specific aim 1 is to measure endothelial function using reactive hyperemia peripheral arterial tonometry (RH-PAT) before and after treatment with Vit D replacement therapy. Specific Aim 2 is to measure levels of inflammation before and after treatment with Vit D replacement therapy. These aims will test the hypotheses that Vit D repletion will improve endothelial function and reduce the levels of detectable inflammation in the plasma of these subjects.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
New York
-
Bronx, New York, Forente stater, 10461
- Jacobi Medical Center
-
Bronx, New York, Forente stater, 10461
- Montefiore Medical Center / Weiler division
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Male and nonpregnant females greater than 18 years of age
- ≥ 50% angiographic stenosis of at least 1 coronary artery or documented previous revascularization
- Serum 25-hydroxyvitamin D < 20 ng/ml
Exclusion Criteria:
- confinement to a nursing facility, institution or home
- GFR < 60 ml/min (by MDRD equation)
- presence of liver disease
- hypercalcemia
- NYHA class III or IV heart failure
- cardiogenic shock at time of presentation
- current planned or emergent CABG
- prior gastric or small bowel surgery
- pancreatitis
- malabsorption
- inflammatory bowel disease
- autoimmune disease
- active malignancy
- current use of > 800 IU/day of vitamin D
- Current use of dilantin, phenobarbitol, immunosuppressant, or immunostimulant therapy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Sukkerpille
|
Oral capsule, once a week, 12 weeks
|
Aktiv komparator: Ergocalciferol
50,000 units of ergocalciferol once a week for 12 weeks
|
Oral capsule, 50,000 units, once a week, 12 weeks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Endothelial Function
Tidsramme: Baseline and 12 weeks
|
Endothelial function was measured using peripheral arterial tonometry expressed as the reactive hyperemia index.
The index is derived from the ratio of the post-to-pre occlusion peripheral arterial tonometry signal amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm.
Median within subject change in endothelial function as measured by reactive hyperemia peripheral arterial tonometry index in each group is presented.
|
Baseline and 12 weeks
|
Inflammation -
Tidsramme: Baseline and 12 weeks
|
Median within subject change in hs-CRP levels between baseline and week 12 in active and placebo groups
|
Baseline and 12 weeks
|
Inflammation
Tidsramme: Baseline to 12 weeks
|
Median within subject change in interferon-gamma levels between baseline and week 12 in active and placebo groups
|
Baseline to 12 weeks
|
Inflammation
Tidsramme: Baseline to 12 weeks
|
Median within subject change in cxcl-10 .levels between baseline and week 12 in active and placebo groups
|
Baseline to 12 weeks
|
Inflammation
Tidsramme: Baseline to week 12
|
Median within subject change in IL-12 levels between baseline and week 12 in active and placebo groups
|
Baseline to week 12
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Seth I Sokol, MD, Jacobi Medical Center
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Ernæringsforstyrrelser
- Avitaminose
- Mangelsykdommer
- Underernæring
- Koronararteriesykdom
- Myokardiskemi
- Koronar sykdom
- Betennelse
- Vitamin D-mangel
- Fysiologiske effekter av legemidler
- Mikronæringsstoffer
- Vitaminer
- Bone Density Conservation Agents
- Kalsiumregulerende hormoner og midler
- Vitamin d
- Ergocalciferoler
Andre studie-ID-numre
- AHA Award #0885041N
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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