Clinical Trial: Role of Antioxidants Supplementation in Chronic Pancreatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Antioxidant Supplementation on Pain, Antioxidant Profile and Oxidative Stress in Patients With Chronic Pancreatitis

Brief Summary: Chronic pancreatitis is a progressive inflammatory disease of the pancreas that presents with abdominal pain and in late stages may cause diabetes and malnutrition. The pain may be incapacitating and may affect patients physically, mentally and socially. Pain due to chronic pancreatitis is difficult to treat. Oxidative stress and free radical mediated injury has been shown to cause pancreatic inflammation. It has been shown that patients with chronic pancreatitis are deficient in micronutrients and natural antioxidants such as b-carotene, vitamin E and C etc. Studies have suggested that antioxidant supplementation may help to combat pain in these patients. Antioxidant supplementation may decrease the oxidative stress and boost the antioxidant status, thereby resulting in pain relief. The investigators have planned to perform a trial to study the effect of antioxidant supplementation on pain relief in patients with chronic pancreatitis.

Detailed Summary:

INTRODUCTION Chronic pancreatitis (CP) is a progressive inflammatory disease of the pancreas accompanied by abdominal pain and in late stages, by exocrine and endocrine insufficiency. The etiology of CP include alcohol abuse, hereditary, ductal obstruction, tropical pancreatitis, systemic diseases (systemic lupus erythematosus and cystic fibrosis etc.), and idiopathic. Alcohol abuse accounts for 70-80% of cases of chronic pancreatitis in the West and about 40% in India. The intensity of injury depends on the duration and amount of alcohol consumed. Hereditary pancreatitis transmitted as an autosomal dominant trait accounts for a small subset of all cases of CP, and occurs due to mutation in cationic trypsinogen gene. Pancreatic duct obstruction may be secondary to trauma, pseudocysts, calcific stones or tumors and leads to obstructive CP (1). Tropical pancreatitis is a condition of unknown etiology that is seen predominantly in south India and other tropical areas of the World. Young patients are commonly affected with this disease. Cassava consumption had been proposed as an etiological factor due to its cyanogenic glycoside content however no epidemiological study has proved this hypothesis (2). Malnutrition has been suggested as an etiological factor in tropical pancreatitis. Idiopathic pancreatitis accounts for a substantial number of cases.

Many recent studies have emphasized a role for Reactive Oxygen Radicals (ROR) in the development of oxidative stress and hence inflammation in the pathogenesis of chronic pancreatitis. Increased oxidative stress probably results from increased exposure to xenobiotics. Xenobiotics are chemical substances present in the environment to which human beings are constantly exposed. It is conceivable that many of these xenobiotics are metabolized in pancreas that contains cytochrome P450 (CYP450) enzymatic system. The metabolism of xenobi
Sponsor: All India Institute of Medical Sciences, New Delhi

Current Primary Outcome: Reduction in the number of painful days per month due to chronic pancreatitis [ Time Frame: 6 months ]

Original Primary Outcome: Reduction in the number of painful days per month due to chronic pancreatitis

Current Secondary Outcome:

  • Decrease in no. of severe attacks requiring hospitalization [ Time Frame: 6 months ]
  • Percentage of patients who are pain-free [ Time Frame: 6 months ]
  • Increase in markers of antioxidant defense in the intervention group compared to placebo group and decrease in oxidative stress parameters in patients after intervention compared to placebo [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Decrease in no. of severe attacks requiring hospitalization
  • Percentage of patients who are pain-free
  • Increase in markers of antioxidant defense in the intervention group compared to placebo group and decrease in oxidative stress parameters in patients after intervention compared to placebo


Information By: All India Institute of Medical Sciences, New Delhi

Dates:
Date Received: April 26, 2006
Date Started: October 2003
Date Completion:
Last Updated: January 28, 2009
Last Verified: January 2009