Role of Antioxidants Supplementation in Chronic Pancreatitis - Full Text View

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. We 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	Drug: Antioxidants	Phase III

MedlinePlus related topics:

Antioxidants Pancreatic Diseases Stress

ChemIDplus related topics:

Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Selenium Ascorbic acid Carotenoids beta Carotene Methionine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

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
Antioxidants: Active Comparator Intervention was done with antioxidants	Drug: Antioxidants 600microgm selenium, 0.54g vitamin C, 9000IU beta-carotene, 270IU vitamin E, 2g methionine per day, daily, in divided doses for 6 months
Placebo: Placebo Comparator	Drug: Antioxidants 600microgm selenium, 0.54g vitamin C, 9000IU beta-carotene, 270IU vitamin E, 2g methionine per day, daily, in divided doses for 6 months

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, Delhi
	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.

Study ID Numbers:	IR-131
First Received:	April 26, 2006
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00319358
Health Authority:	India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:

chronic pancreatitis

antioxidant supplementation

oxidative stress

Study placed in the following topic categories:

Tocopherol acetate

Beta Carotene

Stress

Pain

Alpha-Tocopherol

Tocopherols

Selenium

Vitamin E

Digestive System Diseases

Pancreatic Diseases

Carotenoids

Pancreatitis

Ascorbic Acid

Pancreatitis, Chronic

ClinicalTrials.gov processed this record on October 06, 2008

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