- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01115842
Vitamin D and Inflammatory Cytokine Levels After Acute Myocardial Infraction (MI)
Intervention Study Measuring Inflammatory Cytokine Levels in the Serum of Patients Who Underwent an Acute MI, and the Influence of Vitamin D on These Levels
Vitamin D is known to have immune-modulator effects including suppression of proinflammatory cytokine expression and regulation of immune cell activity. Vitamin D supplementation has been associated with a reduction in pro-inflammatory cytokines in patients with heart failure, and vitamin D deficiency has been associated with higher rates of myocardial infarcts. The levels of pro and anti-inflammatory cytokines also effect the outcome after acute coronary events.
The proposed interventional study is targeted as a feasibility study targeted at assessing the role of vitamin D as an anti-inflammatory mediator.
The study is planned as a randomized open label interventional trial. The study will be conducted of 50 adult patients (25 interventional group, 25 control), all from the internal ward in "Meir" medical center. Patients which are admitted after an acute coronary event will be randomized to the Vitamin D supplementation group or to the control group. the vitamin D group will receive 4000IU per day of vitamin D for five days. Cytokine levels will be measured at day 1 and at day 5. follow up will be continued for 6 months
Primary end point:
Levels of immune mediating cytokines (CRP, TNF-α. Il-2, IL-6, IL-12 and IL-10) after a five day intervention in patients serum.
Secondary endpoints:
Any major cardiovascular event within follow-up period. Any death of any cause during follow-up period
Expected results:
the investigators expect vitamin D supplementation after a pro-inflammatory state such as an acute coronary event, combined with conventional therapy, to result in decreased levels of inflammatory serum bio-markers.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Inclusion criteria:
- Acute coronary syndrome (as defined previously).
- No advanced renal disease (creatinine levels < 1.8 for men and 1.5 for women).
- No known parathyroid or calcium homeostasis abnormalities
- Baseline Calcium levels within normal limits.
- No vitamin D supplementation taken within 4 months of current admission.
- No coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- No coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents).
- No participation in other interventional studies.
- Signing an informed consent form.
Exclusion criteria:
- Advanced renal failure
- Abnormal serum calcium levels upon admission
- Primary parathyroid or calcium homeostasis abnormalities.
- Coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- Coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents)
- Participation in other interventional studies.
- Inability or refusal to sign an informed consent.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yoav Arnson, MD
- Número de teléfono: 09-7472899
- Correo electrónico: yoavar@zahav.net.il
Copia de seguridad de contactos de estudio
- Nombre: Howard Amital, MD, MHA
- Número de teléfono: 09-7472899
- Correo electrónico: Howard.Amital@clalit.org.il
Ubicaciones de estudio
-
-
-
Kfar-Sava, Israel
- Reclutamiento
- Meir Medical Center
-
Contacto:
- Yoav Arnson
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Acute coronary syndrome (as defined previously).
- No advanced renal disease (creatinine levels < 1.8 for men and 1.5 for women).
- No known parathyroid or calcium homeostasis abnormalities
- Baseline Calcium levels within normal limits.
- No vitamin D supplementation taken within 4 months of current admission.
- No coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- No coexisting immune-mediatory agents (e.g. corticosteroids, anti-TNF or other biological agents).
- No participation in other interventional studies.
- Signing an informed consent form.
Exclusion Criteria:
- Advanced renal failure
- Abnormal serum calcium levels upon admission
- Primary parathyroid or calcium homeostasis abnormalities.
- Coexisting pro-inflammatory conditions (e.g. infection, active autoimmune disease)
- Coexisting immune-mediator agents (e.g. corticosteroids, anti-TNF or other biological agents)
- Participation in other interventional studies.
- Inability or refusal to sign an informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Sin intervención: control
|
|
Experimental: Vitamin D
The patients will be given Vitamin D - 4000IU per day for 5 days (Day 1 through 5)
|
Vitamin D 4000IU per day for 5 days
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
inflammatory cytokine levels
Periodo de tiempo: 5 days of treatment
|
CRP, TNF-α.
Il-2, IL-6, IL-12 and IL-10
|
5 days of treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
MACE and all cause mortality
Periodo de tiempo: within 6 months
|
Major acute coronary events (MACE)include:
|
within 6 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yoav Arnson, MD, Meir Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MMC10184-2009CTIL
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