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AzTrials

Non-Alcoholic Fatty Liver DiseasePhase 3NCT04411862

Efficacy of Phosphatidylcholine in NAFLD

A Phase 3 study testing Phosphatidyl Choline and Lifestyle modification in people with Non-Alcoholic Fatty Liver Disease, run by Nehal Abou Seada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-Alcoholic Fatty Liver Disease
What is being tested?
Phosphatidyl Choline and Lifestyle modification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
2 Jan 2016to 1 Jul 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 :

Who cannot join

  • 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

About this study

Official title: Efficacy of Phosphatidylcholine in Addition to Behavior Therapy by Clinical Pharmacist in the Management of Non Alcoholic Fatty Liver (NAFLD)

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.

Read the 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.

Being tested
Phosphatidyl Choline, Lifestyle modification
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Phosphatidyl CholineDietary supplement

    2.1 g Phosphatidylcholine daily in addition to lifestyle modification

  • Lifestyle modificationBehavioural

    Also called Behavior therapy, Health education

    Lifestyle modification and health education by Clinical Pharmacist

Study groups in NCT04411862
Study groupRoleWhat they receive
Intervention GroupExperimental50 Participants with NAFLD that receive lifestyle modification by Clinical Pharmacist plus Phosphatidylcholine two soft capsules 3 times daily(2.1 g per day) for 6 month
Receives: Dietary Supplement: Phosphatidyl Choline; Behavioral: Lifestyle modification
Control GroupActive comparator50 Participants with NAFLD that receive only lifestyle modification by Clinical Pharmacist
Receives: Behavioral: Lifestyle modification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change from baseline Body Mass Index (BMI) at 3 and 6 month

    person's weight in kilograms divided by the square of the person's height in metres (kg/m2).

    Measured: baseline, at 3 and 6 month

  2. change from baseline liver stiffness at 3 and 6 month

    Liver Stiffness and fibrosis score measured by Transient elastography (Fibroscan) F0 = no fibrosis F1 = portal fibrosis without septa F2 = portal fibrosis with few septa F3 = numerous septa without cirrhosis F4 = cirrhosis

    Measured: baseline , at 3 and 6 month

  3. change from baseline Lipid Profile

    Total cholesterol ,Triglyceride ,Low Density Lipoprotein ,High Density Lipoprotein

    Measured: baseline , at 3 and 6 month

  4. change from baseline Oxidative stress markers

    malonaldehyde (MDA) as an index of lipid peroxidation by colorimetric assay

    Measured: baseline , at 3 and 6 month

  5. change from baseline NAFLD score at 3 and 6 month

    NAFLD Fibrosis Score is based on six readily available variables (age, BMI, hyperglycemia, albumin, platelet count, AST/ALT ratio) and it is calculated using published formula (http: //naflds- core.com) . A low cutpoint (score < -1.455) signified the absence of advanced fibrosis, whereas a high cutpoint (score> 0.676) identified advanced fibrosis.

    Measured: baseline , at 3 and 6 month

  6. change from baseline homeostasis model assessment Insulin resistance HOMA IR scores at 3 and 6 month

    HOMA IR scores <3 normal HOMA IR scores >5 severe insulin resistance 3 to 5 moderate insulin resistance

    Measured: baseline , at 3 and 6 month

Secondary outcomes (1)

  1. change from baseline Complete Blood Picture at 3 and 6 month

    platelet count

    Measured: baseline , at 3 and 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2020
  2. Study start2 Jan 2016
  3. Primary completion3 Jan 2019
  4. Study completion1 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Shams University Hospitals and Ain Shams Specialized Hospital outpatient Gastroenterology Clinics.
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04411862
Sponsor's protocol ID
NAFLD
Status last verified
Jun 2020
First submitted
10 May 2020
Last updated
4 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 12485966

  • 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.

    PubMed 27062661

  • 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.

    PubMed 23297154

  • 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.

    PubMed 29118867

  • 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.

    PubMed 27217791

  • 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.

    PubMed 28714183

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phosphatidyl Choline and Lifestyle modification in people with Non-Alcoholic Fatty Liver Disease, run by Nehal Abou Seada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline Body Mass Index (BMI) at 3 and 6 month (time frame: baseline, at 3 and 6 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04411862, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.

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