Exploring the Effects of Genetic Variants and Inflammation on Vitamins Supplementation Treatment Outcomes in Epilepsy

Not Applicable

• Conditions: Epilepsy
• Interventions: Dietary Supplement: Multi-vitamin supplementation

• Registration Number: NCT04488172
• Lead Sponsor: National Cheng-Kung University Hospital

Brief Summary

The management of patients with epilepsy is focused on controlling seizures, avoiding treatment side effects, and restoring quality of life. However, about 30% of people are antiepileptic drugs (AEDs) resistance epilepsy after the adequate trials of two AEDs treatment. Genetic factors may contribute to the high interindividual variability in response or adverse effects (such as weight gain and altered lipid profiles) to AEDs. What's more, previous observational studies indicated that vitamin deficiency, such as vitamin B6, is common in patients with epilepsy due to epilepsy itself, AEDs use, or both. Therefore, investigators aim to (1) evaluate the impact of genetic variants on AED and multi-vitamins supplementation in epilepsy, and (2) establish the pharmacogenomics knowledge base of AED and multi-vitamins supplementation on clinical effectiveness in patients with epilepsy.

Detailed Description

In the current study, investigators will evaluate the association among the genetic polymorphisms, epilepsy, and multi-vitamins supplementation from Taiwan Biobank and will further investigate potential genes related to vitamins signal pathways (especially vitamin B6, B9, D, E, and Q) involved in epilepsy. These results will not only generate the field of AEDs pharmacogenomics for further study, but also provide new potential treatment targets that may involve in epilepsy therapeutics. The clinical outcomes indicate disease severity, body weight, metabolic indices (i.e., the fasting levels of lipid), HRQoL, anxiety and depression scores. All outcome indicators will be repeated measured at baseline and after 1, 3 and 6 months multi-vitamins supplementation. All of the participants will be assessed the genotypes.

Study Timeline

• Study Start: 2015-04-07
• Status Verified: 2020-02
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-23
• Last Update Submitted: 2020-07-23
• Study First Posted: 2020-07-27
• Last Update Posted: 2020-07-27
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnostic criteria of epilepsy
• Receive anti-epileptic drugs (AEDs)

Exclusion Criteria

• Have an organic mental disorder, mental retardation, dementia, or other diagnosed neurological illness
• Have a surgical condition or a major physical illness
• Pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epilepsy subjects	Multi-vitamin supplementation	Receiving multi-vitamins supplementation (B6, B9, D, E, Q10) for 6 months trial

Primary Outcome Measures

Name	Time	Method
Seizure severity	6 months	Number of seizure attack per month

Secondary Outcome Measures

Name	Time	Method
Medication Compliance	6 months	Assessing using Morisky Medication Adherence Scale (MMAS)

Trial Locations

Locations (1)

National Cheng Kung University (NCKU) Hospital; 🇨🇳 Tainan, Taiwan