Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity

NCT05905185 | Completed Phase 4 DMC

• 1 other identifier: GUP 2018-052
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Does tocotrienol-rich fraction vitamin E supplementation improve the level of liver steatosis by reducing the level of DNA damage?
3. 3.consume daily either a dose of 50 mg of tocotrienol-rich fraction (TRF) vitamin E or a placebo for 6 months.
4. 4.Routine clinical assessments include weight, height, waist circumference, and BMI. Fasting glucose, and fasting serum lipid.
5. 5.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.

Conditions

Obesity

Keywords

obesity; Non-alcoholic Fatty Liver Disease; Children; Tocotrienol-Rich Fraction Vitamin E

Outcome Measures

Primary Outcomes (5)

• Mean difference of fibrosis score, inflammation (activity) score and steatosis score

  Serum LiverFASt level is a blood test to detect the degree and stage of: fibrosis (0-1), inflammation (0-1), and steatosis (0-1) scores. The higher the score indicates the higher the degree of fibrosis, inflammation and steatosis. These measurements were taken at the baseline and at the end of trial.

  Six months

• Mean difference of fasting blood glucose

  Fasting blood glucose levels were measured at the baseline and at the end of trial

  6 months

• Mean difference in aspartate aminotransferase & alanine aminotransferase levels

  Aspartate aminotransferase \& alanine aminotransferase levels were measured at the baseline and at the end of trial.

  6 months

• Mean difference in apolipoprotein-A1, triglycerides, total cholesterol levels

  Total cholesterol, triglycerides, apolipoprotein-A1 levels were measured at the baseline and at the end of trial

  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

  Transient elastography was performed to measure controlled attenuation parameter (%) and liver stiffness (kPa) at the baseline and at the end of trial

  6 months

Secondary Outcomes (3)

• Mean difference in tail length to represent DNA damage

  6 months

• Mean difference in the interleukin-6, TNF-alpha and interferon-gamma

  6 months

• Mean difference in the body mass index (percentile)

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Sime Darby Bioganic Sdn. Bhd, Malaysia provided the TRF pills that were used in the study. 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. During a period of six months, the patients were instructed to consume oral TRF (50 mg) daily

Drug: Tocotrienol-rich fraction vitamin E (TRF)

Placebo

PLACEBO COMPARATOR

During a period of six months, the patients were instructed to consume oral placebo (50 mg) pills daily.

Drug: Placebo

Interventions

Tocotrienol-rich fraction vitamin E (TRF) DRUG

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.

Treatment

Placebo DRUG

50mg of Placebo

Placebo

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children aged 13 - 18 years old
• Overweight or obese (BMI percentile range ≥ 85%)
• Able to swallow small oral soft gel capsule
• Diagnosis of NAFLD confirmed by presence of fatty liver detected by abdominal ultrasound and controlled attenuation parameter (CAP) score of \>263
• Elevated alanine transaminase (ALT) ≥ 2 fold upper limits (26 U/L for boys and 22 U/L for girls)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

National University Of Malaysia

Kuala Lumpur, Malaysia

Location

Related Publications (1)

• Al-Baiaty FDR, Ishak S, Mohd Zaki F, Masra F, Abdul Aziz DA, Wan Md Zin WN, Yee Hing E, Kuthubul Zaman AS, Abdul Wahab N, Muhammad Nawawi KN, Hamid Z, Raja Ali RA, Mokhtar NM. Assessing the efficacy of tocotrienol-rich fraction vitamin E in obese children with non-alcoholic fatty liver disease: a single-blind, randomized clinical trial. BMC Pediatr. 2024 Aug 20;24(1):529. doi: 10.1186/s12887-024-04993-8.

  PMID: 39160468 DERIVED

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Norfilza Mohd Mokhtar

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: June 15, 2023
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 21, 2022
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)