- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01689779
High Dose Preoperative Cholecalciferol Supplementation and Perioperative Vitamin D Status
29 de agosto de 2017 actualizado por: Sadeq A. Quraishi, Massachusetts General Hospital
Effect of High-dose Cholecalciferol Supplementation on Perioperative Vitamin D Status in Colorectal Surgery Patients
A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of surgical site infections (SSIs).
At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems.
The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
While vitamin D insufficiency [25(OH)D <30 ng/mL] is common in the general population, hypovitaminosis D may affect 40-80% of patients in the perioperative setting.
Recent evidence also suggests that surgical stress may be associated with a 40% reduction in circulating 25(OH)D levels when compared to preoperative values.
Moreover, the derangement in perioperative 25(OH)D levels may be sustained for up to 3 months after surgery.
This finding has potential implications regarding modifiable risk factors for surgical site infections (SSIs), which account for nearly 40% of all nosocomial infections.
On aggregate, SSIs result in 3.7 million extra hospital days per annum and an added burden of $1.6 billion in annual healthcare costs.
A growing body of evidence suggests that robust postoperative immune function is associated with a lower risk of SSIs.
At the same time, vitamin D is increasingly recognized as a key regulator of the innate and adaptive immune systems.
Yet, optimization of perioperative vitamin D status remains grossly understudied.
Although our overarching aim is to study the impact of vitamin D status on SSIs, the focus of the current investigation is to determine whether the administration of a "bolus" oral dose of cholecalciferol (vitamin D3) in the preoperative setting alters vitamin D status in the perioperative setting (compared to a placebo).
The investigators elected to conduct the current study in patients who will undergo colorectal surgery since these patients are historically at higher risk of developing SSIs and therefore would be ideal for future investigations.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Men and women;
- 18 years or older;
- Scheduled for elective (non-emergent) colorectal surgery;
- Cleared for anesthesia; and
- Expected to stay overnight following surgery
Exclusion Criteria:
- Scheduled for a purely laparoscopic procedure;
- Diagnosis of a terminal illness and/or in hospice care;
- Inability to sign informed consent;
- Inability to comply with study protocol;
- Intending to start vitamin D supplementation within 30 days of surgery;
- Intending to leave the Boston area during the follow-up period;
- History of renal stones or hypercalcemia;
- Medical conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma primary hyperparathyroidism)
- History of hypercalcemia
- History of severe anemia (Hematocrit <25%)
- Medications that affect vitamin D metabolism (e.g. anti-epileptics, tuberculosis medication); and
- Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Cholecalciferol
A maximum of 40 patients will receive a one-time oral dose of 100,000 IU cholecalciferol 3-7 days before their scheduled elective surgery.
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active drug
Otros nombres:
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Comparador de placebos: Placebo
A maximum of 40 patients will receive a one-time oral sugar pill 3-7 days before their scheduled elective surgery.
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comparator drug
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent (%) Change in 25(OH)D 5 Days Following Supplementation With 100,000 IU Cholecalciferol
Periodo de tiempo: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
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3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs.
placebo) during their pre-op assessment.
They will also have their baseline vitamin D status measured during this initial visit.
The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37
|
Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
|
Percent (%) Change in LL-37 5 Days Following Supplementation With 100,000 IU Cholecalciferol
Periodo de tiempo: Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
|
3-7 days before surgery, patients will receive 100,000 IU of cholecalciferol (vs.
placebo) during their pre-op assessment.
They will also have their baseline vitamin D status measured during this initial visit.
The main study outcome is to determine if 100,000 IU cholecalciferol can be given preoperatively to safely boost vitamin D status.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37
|
Patients will be followed between the initial preoperative evaluation day and an average duration of 5 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent (%) Change in Pre-surgical 25(OH)D Within 24 Hours of Surgery
Periodo de tiempo: Patients will be followed between the day of surgery and 1 day after surgery
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The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of short-term changes in vitamin D status following surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.
|
Patients will be followed between the day of surgery and 1 day after surgery
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Percent (%) Change in Pre-surgical LL-37 Within 24 Hours of Surgery
Periodo de tiempo: Patients will be followed between the day of surgery and 1 day after surgery
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The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of short-term changes in vitamin D status following surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL37.
|
Patients will be followed between the day of surgery and 1 day after surgery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Percent (%) Change in Pre-surgical 25(OH)D 2 Weeks After Surgery
Periodo de tiempo: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
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The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.
|
Patients will be followed between the day of surgery and an average duration of 14 days after surgery
|
Percent (%) Change in Pre-surgical LL-37 2 Weeks After Surgery
Periodo de tiempo: Patients will be followed between the day of surgery and an average duration of 14 days after surgery
|
The goal is to determine whether pre-operative supplementation with 100,000 IU cholecalciferol (vs.
placebo) alters the natural course of changes in vitamin D status within 10-18 days after surgery.
To assess vitamin D status, we will measure: 1) 25(OH)D and 2) LL-37.
|
Patients will be followed between the day of surgery and an average duration of 14 days after surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sadeq A Quraishi, MD, MHA, Massachusetts General Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2013
Finalización primaria (Actual)
1 de mayo de 2015
Finalización del estudio (Actual)
1 de mayo de 2015
Fechas de registro del estudio
Enviado por primera vez
4 de septiembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2012
Publicado por primera vez (Estimar)
21 de septiembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de septiembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
29 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Trastornos Nutricionales
- Enfermedades musculoesqueléticas
- Enfermedades por deficiencia
- Desnutrición
- Enfermedades óseas
- Enfermedades Óseas Metabólicas
- Trastornos del metabolismo del calcio
- Deficiencia de vitamina D
- Raquitismo
- Avitaminosis
- Efectos fisiológicos de las drogas
- Micronutrientes
- Vitaminas
- Agentes de conservación de la densidad ósea
- Hormonas y agentes reguladores del calcio
- Vitamina D
- Colecalciferol
Otros números de identificación del estudio
- 2012P001852
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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