Role of Antioxidants Supplementation in Chronic Pancreatitis - Full Text View

Sponsor:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00319358

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Antioxidants Pancreatitis

U.S. FDA Resources

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

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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).

McCloy R. Chronic pancreatitis at Manchester, UK. Focus on antioxidant therapy. Digestion. 1998;59 Suppl 4:36-48. Review.

ClinicalTrials.gov Identifier:	NCT00319358 History of Changes
Other Study ID Numbers:	IR-131
Study First Received:	April 26, 2006
Last Updated:	January 28, 2009
Health Authority:	India: Ministry of Health

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
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012