- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02140294
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease
Long Term Effect of Aggressive Nutritional Management on Survival in Patients With Alcoholic Liver Disease - A Randomized Control Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients with ALD (Alcoholic Liver Disease) would undergo a detailed clinical evaluation. Information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations, upper GI endoscopic findings and radiological investigations, patients would also be screened for the assessment of nutritional status. Patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. The control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 Kcal per day over and above the standard nutritional counseling from a trained dietician. Both the groups would receive standard medical treatment. The polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months. A record would be kept for the medications taken by the patients.
All the patients would be followed up at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after inclusion. Clinical, nutritional and biological data were collected at each visit. All these patients would receive standard treatment of cirrhosis consisting of withdrawal from alcohol along with symptomatic treatment including B vitamins, diuretics, salt restriction, lactulose, beta blockers, and antibiotics after bacteriological samples if needed. All patients would receive endoscopic surveillance for portal hypertension. An adequate prophylaxis by ligation or beta blockers would be performed as needed. The patients with a past history of spontaneous bacterial peritonitis will receive antibiotic prophylaxis.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Delhi
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New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All consecutive malnourished patients with ALD aged between 18 to 65 years of either gender would be enrolled.
- Abstinence of three months.
Exclusion Criteria:
- Severe alcoholic hepatitis
- Uncontrolled complication of the cirrhosis (variceal bleeding, infection, etc.),
- Hepatocellular carcinoma
- Ongoing corticosteroid treatment
- Co morbidities e.g. chronic renal insufficiency & Acquired immunodeficiency syndrome.
- Refusal to participate in the trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Polymeric nutritional supplement
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Comparador activo: Standard Nutritional Treatment
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
To assess long term effect of aggressive nutritional management on survival.
Periodo de tiempo: 1 Year
|
1 Year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To assess long term effect of aggressive nutritional management on improvement in nutritional status.
Periodo de tiempo: 1 Year
|
Nutritional Status will be measured by Royal Free Hospital-Global Assessment (RFH-GA) method.
|
1 Year
|
To assess long term effect of aggressive nutritional management on onset or progression of complication.
Periodo de tiempo: 1 Year
|
1 Year
|
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To assess the effect of nutritional therapy on Health-related quality of life
Periodo de tiempo: 1 Year
|
1 Year
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ILBS-ALD-01
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. .
Ensayos clínicos sobre Polymeric nutritional supplements
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Maastricht University Medical CenterDSM Nutritional Products, Inc.; The Netherlands Asthma FoundationTerminadoEnfermedad Pulmonar Obstructiva CrónicaPaíses Bajos
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Maastricht University Medical CenterDSM Nutritional Products, Inc.Desconocido