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The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis

The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04312984
Enrollment
30
Registered
2020-03-18
Start date
2015-11-30
Completion date
2015-12-23
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis

Brief summary

This is a anonymised case note study looking at the long term outcomes of patients with Chronic Pancreatitis on micro nutrient antioxidant treatment.

Detailed description

Chronic pancreatitis is the medical term for chronic inflammation of the pancreas. This illness is associated with long-term abdominal pain. In the 1980s it was proposed that chronic pancreatitis was due to a deficiency of protective antioxidants in the pancreas and on this basis antioxidant therapy was introduced. This therapy was highly controversial until a large randomised trial of antioxidant therapy in chronic pancreatitis, undertaken in Manchester showed that 6 months intervention with antioxidant therapy was not associated with any change in pain score or improvement in quality of life. Antioxidant therapy is no longer used in modern day pancreatic practice. However, as with any study, the randomised trial raised some specific questions. First, does treatment for more than 6 months provide benefit? Second, are there disease sub-types of chronic pancreatitis where antioxidant therapy may benefit? Given the lack of contemporary use of antioxidant therapy, this question cannot be answered in a prospective study. However, the case records of the Manchester Royal Infirmary contain information on antioxidant treatment in patients who received this therapy over a prolonged period. Thus the aim of the present study is to review the case notes of patients given a discharge code from the Manchester Royal Infirmary of chronic pancreatitis during the period 1st January 1990 to 1st January 1998 in order to assess whether there is a record of improvement in outcome. Only the case notes will be reviewed and patients will be given an opportunity to opt out. The study accepts the limitations of assessing pain from clinical notes but also notes that more objective findings such as development of diabetes mellitus (a long term complication of chronic pancreatitis) can be assessed from the notes.

Interventions

None listed

Sponsors

Manchester University NHS Foundation Trust
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Patients with Chronic Pancreatitis treated with Long term anti-oxidants

Exclusion criteria

* Cancer, On trials

Design outcomes

Primary

MeasureTime frame
Pain Relief10 years
Insulin Dependence10 years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026