Clinical trial NCT04411862: Efficacy of Phosphatidylcholine in NAFLD
Official title: Efficacy of Phosphatidylcholine in Addition to Behavior Therapy by Clinical Pharmacist in the Management of Non Alcoholic Fatty Liver (NAFLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Shams University Hospitals and Ain Shams Specialized Hospital outpatient Gastroenterology Clinics.
Primary purpose: TREATMENT

Brief summary: This study evaluates efficacy of Phosphatidylcholine in addition to life style modification and patient health education by clinical Pharmacist in the Management of Non Alcoholic Fatty Liver NAFLD. All participants with NAFLD will receive life style intervention and half of them will receive additionally Phosphatidylcholine.

Detailed description: As a result of increasing rates of obesity Non Alcoholic Fatty Liver (NAFLD) is the most common liver disorder affecting 17-46% of adults and parallels the prevalence of Metabolic Syndrome (MetS) and its components which also increases the risk of more advanced disease both in adults and in children.

Its pathogenesis is complex and multifactorial, mainly involving genetic, environmental and metabolic factors. New concepts are constantly appearing in the literature, promising new diagnostic and therapeutic tools. Further studies are needed to better characterize not only NAFLD development but overall NAFLD progression, in order to better identify NAFLD patients at higher risk of metabolic, cardiovascular and neoplastic complications. Pharmacological treatments aimed primarily at improving liver disease should generally be limited to those with biopsy-proven Nonalcoholic steatohepatitis (NASH) and liver ﬁbrosis. Not much therapeutic options for NAFLD are accepted until today besides correction of obesity with hypocaloric diets and physical exercise and controlling hyperglycemia with diet, insulin, or oral hypoglycemic agents. Weight loss generally reduces hepatic steatosis.Essential phospholipid (EPL) as a nutritional supplement is one of the drugs under discussion with significant positive effects as antioxidative, antifibrotic effects and high biocompatibility on NAFLD.

Eligibility criteria: Patients were included in the study when the following criteria to were fulfilled :

Inclusion Criteria:

* fatty liver upon Ultrasonography (US) /Computed Tomography (CT) /Magnetic Resonance Imaging (MRI) with either incidental increased Alanine Aminotransferase (ALT)
* the presence of risk factors related to NAFLD + increased ALT
* symptomatic liver disease +/- hepatomegaly, +/- increased ALT
* homeostasis model assessment-insulin resistance HOMA IR score \> 3
* presence of liver steatosis or stiffness measured by transient elastography
* eligible patients had at least one of the following metabolic comorbidities: hypertension, Type 2 Diabetes Mellitus, overweight/obesity (BMI\>27 kg/m2) serum cholesterol of \> 200 mg/d

Patients were excluded from the study if showing evidence :

Exclusion Criteria:

* if showing evidence of alcoholic or chronic liver disease
* Hepatocellular Carcinoma, autoimmune hepatitis
* end stage liver disease
* treatment with other hepatoprotectants
* other concomitant EPL within 30 days of study initiation
* pregnancy or lactation

Primary outcomes:
measure: change from baseline Body Mass Index (BMI) at 3 and 6 month
timeFrame: baseline, at 3 and 6 month
measure: change from baseline liver stiffness at 3 and 6 month
timeFrame: baseline , at 3 and 6 month
measure: change from baseline Lipid Profile
timeFrame: baseline , at 3 and 6 month
measure: change from baseline Oxidative stress markers
timeFrame: baseline , at 3 and 6 month
measure: change from baseline NAFLD score at 3 and 6 month
timeFrame: baseline , at 3 and 6 month
measure: change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month
timeFrame: baseline , at 3 and 6 month
Secondary outcomes:
measure: change from baseline Complete Blood Picture at 3 and 6 month
timeFrame: baseline , at 3 and 6 month
Other outcomes:
Locations:
Study officials:
References:
citation: National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.
citation: European Association for the Study of the Liver (EASL); European Association for the Study of Diabetes (EASD); European Association for the Study of Obesity (EASO). EASL-EASD-EASO Clinical Practice Guidelines for the management of non-alcoholic fatty liver disease. J Hepatol. 2016 Jun;64(6):1388-402. doi: 10.1016/j.jhep.2015.11.004. Epub 2016 Apr 7. No abstract available.
citation: Chalasani N; Writing Group for American Association for Study of Liver Diseases; American College of Gastroenterology; American Gastroenterology Association practice guideline on Diagnosis and Management of Nonalcoholic Fatty Liver Disease. Reply: To PMID 22488764. Hepatology. 2013 Feb;57(2):853-4. doi: 10.1002/hep.26199. Epub 2013 Jan 7. No abstract available.
citation: Ahmed MH, Noor SK, Bushara SO, Husain NE, Elmadhoun WM, Ginawi IA, Osman MM, Mahmoud AO, Almobarak AO. Non-Alcoholic Fatty Liver Disease in Africa and Middle East: An Attempt to Predict the Present and Future Implications on the Healthcare System. Gastroenterology Res. 2017 Oct;10(5):271-279. doi: 10.14740/gr913w. Epub 2017 Oct 26.
citation: Gundermann KJ, Gundermann S, Drozdzik M, Mohan Prasad VG. Essential phospholipids in fatty liver: a scientific update. Clin Exp Gastroenterol. 2016 May 5;9:105-17. doi: 10.2147/CEG.S96362. eCollection 2016.
citation: Chalasani N, Younossi Z, Lavine JE, Charlton M, Cusi K, Rinella M, Harrison SA, Brunt EM, Sanyal AJ. The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases. Hepatology. 2018 Jan;67(1):328-357. doi: 10.1002/hep.29367. Epub 2017 Sep 29. No abstract available.