Document Detail

The safety and efficacy of oral docosahexaenoic acid supplementation for the treatment of primary sclerosing cholangitis - a pilot study.
MedLine Citation:
PMID:  22129201     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Primary sclerosing cholangitis (PSC) is characterised by progressive inflammatory and fibrotic destruction of the biliary ducts. There are no effective medical therapies and presently high dose ursodeoxycholic acid is no longer recommended due to significant adverse events in a recent clinical trial. Cystic fibrosis transmembrane conductance regulator (CFTR) dysfunction is associated with PSC in both children and adults. Since CFTR dysfunction leads to altered fatty acid metabolism, specifically reduced docosahexaenoic acid (DHA), we hypothesised that DHA supplementation might be an effective therapy for patients with PSC.
AIM: To determine the safety and efficacy of oral DHA supplementation for the treatment of PSC.
METHODS: We conducted a 12 month open-label pilot study to evaluate safety of oral DHA and its effects on serum alkaline phosphatase as a primary outcome measure in 23 patients with PSC. DHA was administered orally at 800 mg twice per day. Secondary outcomes included changes in other liver function tests and fibrosis biomarkers.
RESULTS: A 1.7-fold increase in serum DHA levels was observed with supplementation. The mean alkaline phosphatase level (±S.E.) at baseline was 357.8 ± 37.1 IU compared to 297.1 ± 23.7 IU (P < 0.05) after 12 months of treatment. There were no changes in other liver function tests and fibrosis biomarkers. No adverse events were reported.
CONCLUSIONS: Oral DHA supplementation is associated with an increase in serum DHA levels and a significant decline in alkaline phosphatase levels in patients with PSC. These data support the need for a rigorous trial of DHA therapy in PSC.
C R Martin; P G Blanco; J C Keach; J L Petz; M M Zaman; K R Bhaskar; J E Cluette-Brown; S Gautam; S Sheth; N H Afdhal; K D Lindor; S D Freedman
Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-11-30
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  35     ISSN:  1365-2036     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2011-12-16     Completed Date:  2012-04-13     Revised Date:  2013-07-24    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  255-65     Citation Subset:  IM    
Copyright Information:
© 2011 Blackwell Publishing Ltd.
Department of Neonatology, Beth Israel Deaconess Medical Center, Boston, MA 02215, USA.
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MeSH Terms
Administration, Oral
Alkaline Phosphatase / metabolism
Bile Ducts / drug effects*
Biological Markers / metabolism
Cholangitis, Sclerosing / drug therapy*
Dietary Supplements / adverse effects*
Docosahexaenoic Acids / administration & dosage*,  adverse effects
Liver / drug effects*
Liver Function Tests
Middle Aged
Pilot Projects
Grant Support
Reg. No./Substance:
0/Biological Markers; 25167-62-8/Docosahexaenoic Acids; EC Phosphatase

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