Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00325013
Status:
COMPLETED
Last Update Posted:
2015-03-11
First Post:
2006-05-10
Brief Title:
Evaluation of DHA for the Treatment of PSC
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Evaluation of Docosahexaenoic Acid DHA for the Treatment of Primary Sclerosing Cholangitis PSC
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researches aim to study the effects of DHA component of fish oil on patients with Primary Sclerosing Cholangitis PSC Our hypothesis is that DHA might reverse the problems associated with PSC
Detailed Description:
The etiology of Primary Sclerosing Cholangitis PSC is unknown There are no proven effective therapies and no early markers of the disease to predict which patients with colitis may be at risk to develop PSC
Our group has demonstrated an increased prevalence of CFTR alleles the gene responsible for Cystic Fibrosis CF in patients with PSC which was correlated with decreased CFTR function as measured by Nasal Potential Difference Testing These data suggested that colitis in the setting of CFTR dysfunction may lead to bile duct inflammation and fibrosis As proof of concept we subsequently demonstrated in cftr-- mice that 1 colitis leads to the development of bile duct injury and 2 this is prevented by correction of the CFTR related fatty acid defect with oral Docosahexaenoic Acid DHA Preliminary data in these mice indicates that low PPAR expression in the liver may predispose to inflammation One mechanism by which DHA ameliorates the innate inflammatory response linked to CFTR dysfunction may be through an increase in PPAR expression
Based on these data we hypothesize that CFTR dysfunction may contribute to the pathogenesis of primary sclerosing cholangitis PSC Furthermore correction of the fatty acid abnormality and changes in the innate immune response associated with CFTR dysfunction by oral administration of docosahexaenoic acid DHA an n-3 polyunsaturated fatty acid might be an effective therapy for patients with PSC
Immediate Objectives
To evaluate the effect of DHA therapy on patients with PSC examining
Primary Outcome
serum alkaline phosphatase
Secondary Outcomes
cholangiography
liver biochemistry ALT AST gamma-glutamyl transferase bilirubin albumin prothrombin time
fatty acid profile docosahexaenoic acid arachidonic acid
serumplasma liver fibrosis markers hyaluronic acid tumor necrosis factor-α transforming growth factor-ß type III procollagen peptide
innate immune response peripheral blood monocytes for assessment of cytokine secretion lipoxins and PPAR
clinical data on signs and symptoms
Our group has demonstrated an increased prevalence of CFTR alleles the gene responsible for Cystic Fibrosis CF in patients with PSC which was correlated with decreased CFTR function as measured by Nasal Potential Difference Testing These data suggested that colitis in the setting of CFTR dysfunction may lead to bile duct inflammation and fibrosis As proof of concept we subsequently demonstrated in cftr-- mice that 1 colitis leads to the development of bile duct injury and 2 this is prevented by correction of the CFTR related fatty acid defect with oral Docosahexaenoic Acid DHA Preliminary data in these mice indicates that low PPAR expression in the liver may predispose to inflammation One mechanism by which DHA ameliorates the innate inflammatory response linked to CFTR dysfunction may be through an increase in PPAR expression
Based on these data we hypothesize that CFTR dysfunction may contribute to the pathogenesis of primary sclerosing cholangitis PSC Furthermore correction of the fatty acid abnormality and changes in the innate immune response associated with CFTR dysfunction by oral administration of docosahexaenoic acid DHA an n-3 polyunsaturated fatty acid might be an effective therapy for patients with PSC
Immediate Objectives
To evaluate the effect of DHA therapy on patients with PSC examining
Primary Outcome
serum alkaline phosphatase
Secondary Outcomes
cholangiography
liver biochemistry ALT AST gamma-glutamyl transferase bilirubin albumin prothrombin time
fatty acid profile docosahexaenoic acid arachidonic acid
serumplasma liver fibrosis markers hyaluronic acid tumor necrosis factor-α transforming growth factor-ß type III procollagen peptide
innate immune response peripheral blood monocytes for assessment of cytokine secretion lipoxins and PPAR
clinical data on signs and symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R03DK071851 | NIH | None | httpsreporternihgovquickSearchR03DK071851 |