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Vitamin D Repletion in Coronary Artery Disease

5. august 2013 opdateret af: Seth I. Sokol, M.D.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

100 subjects with angiographically documented CAD and Vit D deficiency will be randomized to 50,000 IU oral ergocalciferol (active treatment group) or placebo (delayed intervention group) once a week for 12 weeks. The investigators will measure endothelial function at randomization and week 12 using RH-PAT and serologically measured adhesion molecules (s-VCAM, s-ICAM, soluble e-selectin). Changes in levels of plasma cytokines and chemokines representing a T-cell activation pathway (IL-12, IFN-g and CXCL-10 - "IFN-g axis") the investigators have linked to coronary atherogenesis (independent of CRP) and poor CV outcomes, will be measured over the 12 week study period. Given published evidence showing that Vit D can influence this T- cell pathway, specific aim 2 will add mechanistic insights to this proposal. High sensitivity C-reactive protein (hs-CRP) will be measured as it is a well established traditional marker of inflammation in CAD and has also been linked to Vit D status.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

96

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Jacobi Medical Center
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center / Weiler division

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Sukker pille
Andet: Sugar pill
Oral capsule, once a week, 12 weeks
Aktiv komparator: Ergocalciferol
50,000 units of ergocalciferol once a week for 12 weeks
Medicin: Ergocalciferol
Oral capsule, 50,000 units, once a week, 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Seth I. Sokol, M.D.

Samarbejdspartnere

Albert Einstein College of Medicine
Yale University
Montefiore Medical Center
American Heart Association
Jacobi Medical Center

Efterforskere

  • Ledende efterforsker: Seth I Sokol, MD, Jacobi Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2008

Primær færdiggørelse (Faktiske)

1. marts 2011

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

26. marts 2012

Først indsendt, der opfyldte QC-kriterier

3. april 2012

Først opslået (Skøn)

4. april 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. august 2013

Sidst verificeret

1. august 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AHA Award #0885041N

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Koronararteriesygdom

Kliniske forsøg med Ergocalciferol

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Sponsorer og samarbejdspartnere

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Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner