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

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Вход / Регистрация

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СъстояниеНабиране

Спонсори

National Cheng-Kung University Hospital

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT04488172

BioSeek: nct04488172

Ключови думи

Резюме

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.

Описание

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.

Дати

Последна проверка:	01/31/2020
Първо изпратено:	07/20/2020
Очаквано записване подадено:	07/22/2020
Първо публикувано:	07/26/2020
Изпратена последна актуализация:	07/22/2020
Последна актуализация публикувана:	07/26/2020
Действителна начална дата на проучването:	04/06/2015
Приблизителна дата на първично завършване:	06/30/2021
Очаквана дата на завършване на проучването:	06/30/2021

Състояние или заболяване

Epilepsy

Интервенция / лечение

Dietary Supplement: Epilepsy subjects

Фаза

Групи за ръце

Arm	Интервенция / лечение
Experimental: Epilepsy subjects Receiving multi-vitamins supplementation (B6, B9, D, E, Q10) for 6 months trial	Dietary Supplement: Epilepsy subjects 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

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	20 Years Да се 20 Years
Полове, допустими за проучване	All
Приема здрави доброволци	Да
Критерии	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

Резултат

Първични изходни мерки

1. Seizure severity [6 months]

Number of seizure attack per month

Вторични изходни мерки

1. Medication Compliance [6 months]

Assessing using Morisky Medication Adherence Scale (MMAS)

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

Ключови думи

тревожност

възпаление

епилепсия

епилептични припадъци

авитаминоза

противогъбично