Effect of vitamin D supplementation in epilepsy
- Conditions
- Health Condition 1: G409- Epilepsy, unspecified
- Registration Number
- CTRI/2020/12/029862
- Lead Sponsor
- This has been submitted to ICMR for funding
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To find out the percentage change in seizure frequency in persons with drug resistant epilepsy (DRE) after 6 months of vitamin D supplementation as compared to placebo treatment with ongoing AEDs therapyTimepoint: 3 years
- Secondary Outcome Measures
Name Time Method