NCT04140136

The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)

The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Malaya · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

There is currently no effective treatment in ALS. Oxidative stress, probably interacting with other neurodegenerative processes, is hypothesized to play a leading role in pathogenesis. These include mechanisms that promote glutamate excitotoxicity, mitochondrial dysfunction and axonal dysfunction. In a transgenic mouse model of fALS that develops a disease with a clinical phenotype similar to ALS, dietary vitamin E supplementation delayed disease onset and slowed progression, although it did not prolong survival. When used as an experimental therapy in human trials, vitamin E did not affect survival significantly, but possibly slowed ALS progression. Two large, prospective epidemiologic studies suggest that longterm use of vitamin E supplements could be inversely associated with risk of ALS or ALS death. In another study, higher baseline serum α-tocopherol was associated with lower subsequent risk of ALS. A modest, non-significant protective effect from supplementation was seen in subjects with baseline serum α-tocopherol levels below median levels. In the current study, we aim to investigate the effects of tocotrienols in patients with ALS, particularly in delaying disease progression as well as assessing its safety profile in this group of patients.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Tocotrienols	Tocotrienols as a potent antioxidant to modulate oxidative stress and inflammatory response
DIETARY_SUPPLEMENT	Placebo	The placebo is similar in appearance, but does not contain tocotrienols and consist of palm oil

Timeline

• Start date: 2019-06-17
• Primary completion: 2020-04-01
• Completion: 2020-09-01
• First posted: 2019-10-25
• Last updated: 2019-10-25

Locations

1 site across 1 country: Malaysia