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Role of Antioxidants Supplementation in Chronic Pancreatitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00319358
First Posted: April 27, 2006
Last Update Posted: January 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
All India Institute of Medical Sciences, New Delhi
  Purpose
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 Intervention Phase
Chronic Pancreatitis Dietary Supplement: Antioxidants Dietary Supplement: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 127
Study Start Date: October 2003
Study Completion Date: October 2006
Arms Assigned Interventions
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
placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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


Locations
India
A.I.I.M.S.
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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
  More Information

Publications:
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).

ClinicalTrials.gov Identifier: NCT00319358     History of Changes
Other Study ID Numbers: IR-131
First Submitted: April 26, 2006
First Posted: April 27, 2006
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:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs