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

Primary Purpose

Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Multi-vitamin supplementation
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring pharmacogenomics, antiepileptic drugs, multi-vitamins supplementation, epilepsy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cheng Kung University (NCKU) HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epilepsy subjects

Arm Description

Receiving multi-vitamins supplementation (B6, B9, D, E, Q10) for 6 months trial

Outcomes

Primary Outcome Measures

Seizure severity
Number of seizure attack per month

Secondary Outcome Measures

Medication Compliance
Assessing using Morisky Medication Adherence Scale (MMAS)

Full Information

First Posted
July 21, 2020
Last Updated
July 23, 2020
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04488172
Brief Title
Exploring the Effects of Genetic Variants and Inflammation on Vitamins Supplementation Treatment Outcomes in Epilepsy
Official Title
Exploring the Effects of Genetic Variants and Inflammation on Individualized Treatment Outcomes of Vitamins Supplementation in Patient With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 7, 2015 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
pharmacogenomics, antiepileptic drugs, multi-vitamins supplementation, epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epilepsy subjects
Arm Type
Experimental
Arm Description
Receiving multi-vitamins supplementation (B6, B9, D, E, Q10) for 6 months trial
Intervention Type
Dietary Supplement
Intervention Name(s)
Multi-vitamin supplementation
Intervention Description
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
Primary Outcome Measure Information:
Title
Seizure severity
Description
Number of seizure attack per month
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Medication Compliance
Description
Assessing using Morisky Medication Adherence Scale (MMAS)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Hua Chang, Ph.D
Phone
886-6-2353535
Ext
5683
Email
huihua@mail.ncku.edu.tw
Facility Information:
Facility Name
National Cheng Kung University (NCKU) Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Hua Chang, PhD
Phone
886-2353535
Ext
5683
Email
huihua@mail.ncku.edu.tw

12. IPD Sharing Statement

Learn more about this trial

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

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