Effect of vitamin D supplementation on seizure frequency in persons with drug resistant epilepsy and its correlation with biomarkers

This has been submitted to ICMR for funding0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•Clinically diagnosed persons with drug resistant epilepsy (definition as per ILAE)
•PWE on stable AEDs treatment regimen for at least 3 months
•Subject having seizure frequency 2 or more per month
•Subject of age 18 to 70 years of either gender.
•Subject with serum level of 25 (OH) vitamin D < 30 ng/ml
•No vitamin D or calcium supplementation in the past 3 months prior to enrolment.
•Ability to maintain seizure diary

•Pregnant or seeking pregnancy, lactating women
•Associated neurological diseases other than epilepsy
•Progressive brain diseases
•Subject undergoing AED tapering
•Patient on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole etc.)
•Patient on antitubercular drugs or any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.)
•Treatments influencing the metabolism of vitamin D (rifamycin, isoniazid, ketoconazole, 5-FU fluorouracil, leucovorin)
•Known hypersensitivity to vitamin D
•Subjects with more than equal to 2 times of normal parathyroid hormone (PTH) level.
•Subject refused to give informed consent
•Poor compliance to AEDs

发起方

This has been submitted to ICMR for funding