Role of Antioxidants Supplementation in Chronic Pancreatitis
This study has been completed.
Sponsor:
All India Institute of Medical Sciences, New Delhi
Information provided by:
All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT00319358
First received: April 26, 2006
Last updated: January 28, 2009
Last verified: January 2009
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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 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:
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).
| 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 June 18, 2013