Evidence mapPaperPMID 39160468Full record

Trial reportBMC pediatrics2024

Assessing the efficacy of tocotrienol-rich fraction vitamin E in obese children with non-alcoholic fatty liver disease: a single-blind, randomized clinical trial.

Farah D R Al-Baiaty, Shareena Ishak, Faizah Mohd Zaki, Farin Masra, Dayang Anita Abdul Aziz, Wan Nurulhuda Wan Md Zin, Erica Yee Hing, Azrina Syarizad Kuthubul Zaman, Norhazlina Abdul Wahab, Khairul Najmi Muhammad Nawawi and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05905185 (Interventional Strategy in Tackling Emerging Non-alcoholic Fatty Liver Disease in Childhood Obesity), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05905185 phase4completednot on this map

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

TypeinterventionalSponsorNational University of MalaysiaRan2020 to 2022Enrolled29ConditionsObesityArmsTocotrienol-rich fraction vitamin E (TRF), Placebo
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Farah D R Al-BaiatyDepartment of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, Bandar Tun RazakKuala Lumpur, 56000, Malaysia.
Shareena IshakDepartment of Pediatrics, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Faizah Mohd ZakiDepartment of Radiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Farin MasraDepartment of Pediatrics, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Dayang Anita Abdul AzizDepartment of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Wan Nurulhuda Wan Md ZinDepartment of Pediatrics, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Erica Yee HingDepartment of Radiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Azrina Syarizad Kuthubul ZamanDepartment of Surgery, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Norhazlina Abdul WahabDepartment of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, Bandar Tun RazakKuala Lumpur, 56000, Malaysia.
Khairul Najmi Muhammad NawawiGastroenterology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Zalina HamidSime Darby Oils Nutrition Sdn. Bhd, Jalan PJU 1A/7, 47301 Petaling , Ara DamansaraSelangor, Malaysia.
Raja Affendi Raja AliGUT Research Group, Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Kuala Lumpur, Malaysia.
Norfilza Mohd MokhtarDepartment of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, Cheras, Bandar Tun RazakKuala Lumpur, 56000, Malaysia. norfilza@ppukm.ukm.edu.my.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChildhood obesity is a growing concern, and non-alcoholic fatty liver disease (NAFLD) is a significant consequence. Currently, there are no approved drugs to treat NAFLD in children. However, a recent study explored the potential of vitamin E enriched with tocotrienol (TRF) as a powerful antioxidant for NAFLD. The aims of the present study were to investigate the effectiveness and safety of TRF in managing children with obesity and NAFLD.

methodsA total of 29 patients aged 10 to 18 received a daily oral dose of 50 mg TRF for six months (January 2020 to February 2022), and all had fatty liver disease were detected by ultrasonography and abnormally high alanine transaminase levels (at least two-fold higher than the upper limits for their respective genders). Various parameters, including biochemical markers, FibroScan, LiverFASt, DNA damage, and cytokine expression, were monitored.

resultsAPO-A1 and AST levels decreased significantly from 1.39 ± 0.3 to 1.22 ± 0.2 g/L (P = 0.002) and from 30 ± 12 to 22 ± 10 g/L (P = 0.038), respectively, in the TRF group post-intervention. Hepatic steatosis was significantly reduced in the placebo group from 309.38 ± 53.60 db/m to 277.62 ± 39.55 db/m (p = 0.048), but not in the TRF group. Comet assay analysis showed a significant reduction in the DNA damage parameters in the TRF group in the post-intervention period compared to the baseline, with tail length decreasing from 28.34 ± 10.9 to 21.69 ± 9.84; (p = 0.049) and with tail DNA (%) decreasing from 54.13 ± 22.1to 46.23 ± 17.9; (p = 0.043). Pro-inflammatory cytokine expression levels were significantly lower in the TRF group compared to baseline levels for IL-6 (2.10 6.3 to 0.7 1.0 pg/mL; p = 0.047 pg/mL) and TNF-1 (1.73 5.5 pg/mL to 0.7 0.5 pg/mL; p = 0.045).

conclusionThe study provides evidence that TRF supplementation may offer a risk-free treatment option for children with obesity and NAFLD. The antioxidant and anti-inflammatory properties of TRF offer a promising adjuvant therapy for NAFLD treatment. In combination with lifestyle modifications such as exercise and calorie restriction, TRF could play an essential role in the prevention of NAFLD in the future. However, further studies are needed to explore the long-term effects of TRF supplementation on NAFLD in children.

trial registrationThe study has been registered with the International Clinical Trial Registry under reference number (NCT05905185) retrospective registration on (15/06/2023).

Indexed as

AntioxidantsNon-alcoholic Fatty Liver DiseasePediatric ObesityTocotrienolsAdolescentChildFemaleHumansMaleSingle-Blind MethodTreatment OutcomeVitamin EAntioxidantsTocotrienolsVitamin EAnti-inflammatory agentAntioxidantsNon-alcoholic fatty liver diseaseOxidative stressTocotrienols

Identifiers

PMID39160468
PMCPMC11334366

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.