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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04488172
• Other study ID #: A-ER-105-489
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2015
• Est. completion date: July 2021

Study information

• Verified date: February 2020
• Source: National Cheng-Kung University Hospital
• Contact: Hui Hua Chang, Ph.D
• Phone: 886-6-2353535
• Email: huihua[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Inflammation

Intervention

Dietary Supplement:
• Multi-vitamin supplementation
Vitamin B6:100 mg/day Vitamin B9: 5 mg/day Vitamin D: 1000 IU/day Vitamin E: 400 IU/day Co-Q10: 100 mg/day

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University (NCKU) Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure severity	Number of seizure attack per month	6 months
Secondary	Medication Compliance	Assessing using Morisky Medication Adherence Scale (MMAS)	6 months