Clinical trial
Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity
Name
GUP 2018-052
Description
The goal of this clinical trial is to investigate the effects of tocotrienol-rich fraction vitamin E supplementation on liver enzymes in overweight and obese children with non-alcoholic fatty liver disease as compared to placebo.
The main question\[s\] it aims to answer are:
1. Does supplementation of tocotrienol-rich fraction vitamin E reduce the level of liver enzymes and improve liver steatosis in non-alcoholic fatty liver disease among overweight and obese children?
2. Does tocotrienol-rich fraction vitamin E supplementation improve the level of liver steatosis by reducing the level of DNA damage?
Participants will :
1. consume daily either a dose of 50 mg of tocotrienol-rich fraction (TRF) vitamin E or a placebo for 6 months.
2. Routine clinical assessments include weight, height, waist circumference, and BMI. Fasting glucose, and fasting serum lipid.
3. The following investigations were performed upon recruitment and following 6 months of intervention: (i) liver biomarker and enzymes; (ii) DNA damage; (iii) TNFα, IL-6 and IFN-gamma genes; (iv) Fibroscan.
Trial arms
Trial start
2020-01-01
Estimated PCD
2022-01-01
Trial end
2022-01-21
Status
Completed
Phase
Early phase I
Treatment
Tocotrienol-rich fraction vitamin E (TRF)
The 50 mg of vitamin E isomers in the TRF included 17.1 mg of α-tocopherol ,18.28 mg of α- tocotrienol, 2.02 mg of β-tocotrienol, 22.3 mg of γ-tocotrienol and 7.4 mg of δ-tocotrienol.
Arms:
Treatment
Placebo
50mg of Placebo
Arms:
Placebo
Size
29
Primary endpoint
Mean difference of fibrosis score, inflammation (activity) score and steatosis score
Six months
Mean difference of fasting blood glucose
6 months
Mean difference in aspartate aminotransferase & alanine aminotransferase levels
6 months
Mean difference in apolipoprotein-A1, triglycerides, total cholesterol levels
6 months
Mean difference of liver steatosis and liver stiffness, measured by controlled attenuation parameter (CAP) score in percentage and kPa respectively, by transient elastography
6 months
Eligibility criteria
Inclusion Criteria:
1. Children aged 13 - 18 years old
2. Overweight or obese (BMI percentile range ≥ 85%)
3. Able to swallow small oral soft gel capsule
4. Diagnosis of NAFLD confirmed by presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score of \>263
5. Elevated alanine transaminase (ALT) ≥ 2 fold upper limits (26 U/L for boys and 22 U/L for girls)
Exclusion Criteria:
* Evidence of other primary chronic liver diseases (as determined by clinical and standard investigations) - e.g. Hepatitis B, C infections, autoimmune hepatic disorders.
* Not on any dietary supplements.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 29, 'type': 'ACTUAL'}}
Updated at
2023-06-15
1 organization
1 product
1 drug
1 indication
Organization
National University of MalaysiaIndication
ObesityDrug
Varlilumab