NCT00319358

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2003

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 29, 2009

Status Verified

January 1, 2009

First QC Date

April 26, 2006

Last Update Submit

January 28, 2009

Conditions

Chronic Pancreatitis

Keywords

chronic pancreatitisantioxidant supplementationoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Reduction in the number of painful days per month due to chronic pancreatitis

    6 months

Secondary Outcomes (3)

  • Decrease in no. of severe attacks requiring hospitalization

    6 months

  • Percentage of patients who are pain-free

    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

    6 months

Study Arms (2)

Antioxidants

ACTIVE COMPARATOR

Intervention was done with antioxidants

Dietary Supplement: Antioxidants

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

AntioxidantsDIETARY_SUPPLEMENT

600microgm selenium, 0.54g vitamin C, 9000IU beta-carotene, 270IU vitamin E, 2g methionine per day, daily, in divided doses for 6 months

Also known as: Betamore G, Osper Pharmanautics, India
Antioxidants
PlaceboDIETARY_SUPPLEMENT

placebo

Placebo

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A.I.I.M.S.

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (2)

  • 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).

    BACKGROUND

  • McCloy R. Chronic pancreatitis at Manchester, UK. Focus on antioxidant therapy. Digestion. 1998;59 Suppl 4:36-48. doi: 10.1159/000051441.

    PMID: 9832634BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Antioxidants

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological FactorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesProtective AgentsPhysiological Effects of DrugsSpecialty Uses of Chemicals

Study Officials

  • Payal Bhardwaj, MSc

    dept. of Gastroenterology, A.I.I.M.S. , New Delhi

    PRINCIPAL INVESTIGATOR

  • Pramod K Garg, MD, DM

    Dept. of Gastroenterology, All India Institute of Medical Sciences, New Delhi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2006

First Posted

April 27, 2006

Study Start

October 1, 2003

Study Completion

October 1, 2006

Last Updated

January 29, 2009

Record last verified: 2009-01

Locations

IN(1)