ProtocolInternational Journal of Clinical Trials
Publication: Effect of vitamin E as an add-on therapy on oxidative stress in patients with epilepsy: a randomized placebo-controlled trial
Int J Clin Trials. 2025;12(3):220-223.DOI10.18203/2349-3259.ijct20252200
Abstract
Background Epilepsy, a chronic neurological disorder, is often complicated by oxidative stress due to long-term antiepileptic drug (AED) use. While preclinical studies suggest vitamin E may mitigate oxidative damage, its clinical efficacy as adjunctive therapy in epilepsy remains underexplored.
Methods This randomized, double-blind, placebo-controlled trial enrolled 60 adults with epilepsy on stable AED therapy at JIPMER, Puducherry (March 2022-March 2024). Participants were allocated to either vitamin E (400 mg/day) or placebo for two months. Primary outcomes included changes in oxidative stress biomarkers [total antioxidant capacity (TAC), catalase, glutathione (GSH), malondialdehyde (MDA)]. Secondary outcomes assessed EEG changes, seizure-free intervals, and metabolic syndrome incidence. Statistical analysis used ANOVA/Kruskal-Wallis for biomarkers and repeated-measures ANOVA for EEG.
Conclusions This study aims to determine whether vitamin E supplementation reduces oxidative stress and improves clinical outcomes in epilepsy patients, potentially informing future antioxidant-based adjunctive therapies. Trial registration: CTRI/2022/04/041902 (Clinical trials registry-India).
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Affiliations
- Department of Pharmacology, JIPMER, Puducherry, India
- Department of Pharmacology, SRM Medical College and Hospital, Chennai, Tamil Nadu, India
- Department of Neurology, JIPMER, Puducherry, India
