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Milk Thistle Clinical Trial in Pediatric NAFLD

ConditionNon-Alcoholic Fatty Liver Disease (NAFLD)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age9-22
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

Pediatric Fatty Liver disease is a growing problem in the United States and is expected to be the leading cause of Liver Transplantation in Adults in 20 years. Following lifestyle changes such as diet restrictions and exercise may be difficult to consistently maintain. The purpose of this study is to investigate alternative medical therapy with an herbal supplement called Milk Thistle (MT) which may improve fatty liver disease and would be easier to follow than diet and exercise.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. In children, obesity is defined as BMI greater than or equal to 95th percentile in weight and overweight is defined as greater than or equal to the 85th percentile to less than the 95th percentile.

3. For participants 18 years or older: Obesity is defined as BMI greater than or equal to 30 kg/m2; overweight is defined as BMI greater than or equal to 25 kg/m2 and less than 30 kg/m2.

b. Evidence of Sonographic presence of hepatic steatosis with greater than 5% steatosis on Ultrasound or FibroScan [with a controlled attenuation parameter (CAP) score of 238 or greater)] prior to start of trial starting.

c. (Or) previous findings on Liver Biopsy consistent with NAFLD including hepatic macro-vesicular steatosis, ballooning degeneration or Mallory Denk Bodies

Disqualifiers

Patients with cardiovascular disorders (such as history of myocardial infarction, stroke, DVT)

Medical conditions including history of malignancy, transplantation, immunologic diseases (rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, autoimmune thyroiditis, idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis etc.), poorly controlled thyroid disease, uncontrolled hypertension.

ALT greater than 200 U/L

AST greater than 200 U/L

Trial design

Design model

Parallel

Treatments tested in this trial

  • Milk thistle (MT)

    Drug

    MT capsules will contain 300 mg of MT with 80% content of Silymarin, standardized to 240mg Silymarin content. Dosing will be based on body weight with maximum dose of 600 mg/day. Dosing will be either 1 or 2 capsules per day based on weight.

  • Placebo

    Drug

    The placebo is consistent of Psyllium husk fiber, in 500mg per capsule composition.

  • Lifestyle Modification

    Behavioral

    The primary instructions for lifestyle modification are: 1. Physical activity goal- 20-30 minutes per day 5 to 7 days per week. The aim is 150 minutes a week and more than 300 calories burnt for each workout. 2. Adequate hydration- 4-5 bottles of water a day. 3. Limitation of sugar-free beverages- once daily and 1-2 (8 oz) cups of skim/1% milk (or dairy alternative) daily. 4. Avoidance of beverages with added sugar such as soda, Kool-Aid, juice, and Gatorade. 5. Ideal consumption- three meals daily(breakfast, lunch, dinner)and one snack. 6. Snack Goal \<200 calories. If a 2nd, 3rd, etc. snack is desired it will only be a vegetable. 7. Five servings of fruits/vegetables per day. 8. Each food we recommend eating should have dietary fiber \>3 grams/serving. Ideally \>5 grams/serving. 9. The given survival guide will have all information regarding serving size and portion allotment. 10. "MyPlate.gov" handout given which will guide participants in relation to portion control.

  • Fibroscan

    Device

    FibroScan will be completed to measure Elastography. Elastography works by emitting small pulse of energy which may be perceived as a vibration which quickly calculated the stiffness of the liver, which correlates to fat deposition and fibrosis.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Milk ThistleExperimental treatment 3 interventions
Group B: PlaceboExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Hepatic biomarker alanine aminotransferase (ALT) as measured by blood test.

Time frame
Up to 12 weeks
2

Hepatic Stiffness (kilopascal, kPa) as measured by FibroScan.

Normal kPa results are usually between 2 and 7 kPa, with the highest possible result of 75 kPa.

Time frame
Up to 12 weeks
3

Percent of Hepatic Steatosis as measured by FibroScan.

Percentage of steatosis will be correlated with the CAP score- 200 to 400db/m2

Time frame
Up to 12 weeks

Secondary outcomes

1

Number of adverse events as measured by patient report.

Time frame
Up to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals Cleveland Medical Center

Lead sponsor

Source ClinicalTrials.gov
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