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Role of Antioxidants Supplementation in Chronic Pancreatitis

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ClinicalTrials.gov Identifier: NCT00319358
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : January 29, 2009
Information provided by:
All India Institute of Medical Sciences, New Delhi

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.

Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Dietary Supplement: Antioxidants Dietary Supplement: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Antioxidant Supplementation on Pain, Antioxidant Profile and Oxidative Stress in Patients With Chronic Pancreatitis
Study Start Date : October 2003
Actual Study Completion Date : October 2006

Arm Intervention/treatment
Active Comparator: Antioxidants
Intervention was done with antioxidants
Dietary Supplement: Antioxidants
600microgm selenium, 0.54g vitamin C, 9000IU beta-carotene, 270IU vitamin E, 2g methionine per day, daily, in divided doses for 6 months
Other Name: Betamore G, Osper Pharmanautics, India

Placebo Comparator: Placebo Dietary Supplement: Placebo

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

Secondary Outcome Measures :
  1. Decrease in no. of severe attacks requiring hospitalization [ Time Frame: 6 months ]
  2. Percentage of patients who are pain-free [ Time Frame: 6 months ]
  3. 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 ]

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CP with significant pain i.e., at least one episode of pain in a month requiring oral analgesic or one episode of severe pain in last three months requiring hospitalization

Exclusion Criteria:

  • Painless disease
  • Current pain more likely due to non-pancreatic origin
  • If the patient already has an intervention in the form decompressive therapy i.e., surgery or endoscopic sphincterotomy/ stenting or ESWL
  • Systemic conditions like CRF, malignancy, hypertension, and pregnancy
  • Complications like pseudocyst, pancreatic abscess
  • Patients who would have received antioxidants in the preceding 4 weeks
  • Narcotic addicts
  • Uncontrolled diabetes
  • Comorbid conditions like liver diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319358

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New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
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Principal Investigator: Payal Bhardwaj, MSc dept. of Gastroenterology, A.I.I.M.S. , New Delhi
Study Director: Pramod K Garg, MD, DM Dept. of Gastroenterology, All India Institute of Medical Sciences, New Delhi
Chouduary A, Garg PK, Tandon RK. The role of oxidative stress in tropical pancreatitis and effect of antioxidants supplementation on pain in patients with tropical pancreatitis. J Gastroenterol. Hepatol. 2001;16(Suppl):A132(Abstract).

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ClinicalTrials.gov Identifier: NCT00319358    
Other Study ID Numbers: IR-131
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: January 29, 2009
Last Verified: January 2009
Keywords provided by All India Institute of Medical Sciences, New Delhi:
chronic pancreatitis
antioxidant supplementation
oxidative stress
Additional relevant MeSH terms:
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Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs