Exploring the Effects of Genetic Variants and Inflammation on Vitamins Supplementation Treatment Outcomes in Epilepsy
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2015
CompletedFirst Submitted
Initial submission to the registry
July 21, 2020
CompletedFirst Posted
Study publicly available on registry
July 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedJuly 27, 2020
February 1, 2020
6.2 years
July 21, 2020
July 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Seizure severity
Number of seizure attack per month
6 months
Secondary Outcomes (1)
Medication Compliance
6 months
Study Arms (1)
Epilepsy subjects
EXPERIMENTALReceiving multi-vitamins supplementation (B6, B9, D, E, Q10) for 6 months trial
Interventions
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
Eligibility Criteria
You may qualify if:
- Diagnostic criteria of epilepsy
- Receive anti-epileptic drugs (AEDs)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University (NCKU) Hospital
Tainan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2020
First Posted
July 27, 2020
Study Start
April 7, 2015
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
July 27, 2020
Record last verified: 2020-02