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Role of Antioxidants Supplementation in Chronic Pancreatitis

NCT00319358 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2009-01-29

No results posted yet for this study

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.

Conditions

  • Chronic Pancreatitis

Interventions

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

DIETARY_SUPPLEMENT

Placebo

placebo

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Payal Bhardwaj, MSc · dept. of Gastroenterology, A.I.I.M.S. , New Delhi

  • Pramod K Garg, MD, DM · Dept. of Gastroenterology, All India Institute of Medical Sciences, New Delhi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Completion
2006-10-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00319358 on ClinicalTrials.gov