The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS)
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|ClinicalTrials.gov Identifier: NCT04140136|
Recruitment Status : Recruiting
First Posted : October 25, 2019
Last Update Posted : October 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Dietary Supplement: Tocotrienols Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy and Safety of Vitamin E Mixed Tocotrienols In Patients With Amyotrophic Lateral Sclerosis (ALS) : A Pilot Exploratory Study|
|Actual Study Start Date :||June 17, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Active Comparator: Treatment group
This is a pilot randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effects of 24-weeks tocotrienols (Tocovid Suprabio) supplementation in ALS patients.The investigational product is to be administered twice daily, at a dose of 400mg per day.
Dietary Supplement: Tocotrienols
Tocotrienols as a potent antioxidant to modulate oxidative stress and inflammatory response
Placebo Comparator: Placebo group
This is a pilot randomized, double-blind, placebo-controlled, parallel-group study to evaluate the effects of 24-weeks tocotrienols (Tocovid Suprabio) supplementation in ALS patients. The placebo is similar in appearance but does not contain tocotrienols and consist of palm oil.
Dietary Supplement: Placebo
The placebo is similar in appearance, but does not contain tocotrienols and consist of palm oil
- Mean change of revised ALS Functional Rating Scale (ALSFRS-R) at baseline and 6 months between treatment group difference. [ Time Frame: 6 months ]Efficacy of oral mixed Tocotrienols in patients with ALS in delaying disease progression as assess based on the cumulative score of ALSFRS-R between treatment group difference at specific time point.
- Number of participants with treatment-related adverse events,haematological,renal and liver profile monitored at every visit [ Time Frame: 6 months ]Safety of oral mixed Tocotrienols in ALS patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04140136
|Contact: Piek Lian Wangfirstname.lastname@example.org|
|Clinical Investigation Centre (CIC)||Recruiting|
|Kuala Lumpur, Malaysia, 59100|
|Contact: Piek Lian Wang +603-79492622 email@example.com|
|Principal Investigator: Nortina Shahrizaila|