- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Delhi
-
New Delhi, Delhi, Indien, 110070
- Institute of Liver & Biliary Sciences
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Polymeric nutritional supplement
|
|
Aktiv komparator: Standard Nutritional Treatment
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
To assess long term effect of aggressive nutritional management on survival.
Tidsram: 1 Year
|
1 Year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
To assess long term effect of aggressive nutritional management on improvement in nutritional status.
Tidsram: 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.
Tidsram: 1 Year
|
1 Year
|
|
To assess the effect of nutritional therapy on Health-related quality of life
Tidsram: 1 Year
|
1 Year
|
Samarbetspartners och utredare
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ILBS-ALD-01
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