Comparison of effect of chronic antiepileptic therapy on trace elements (zinc, copper, selenium and others) level in persons with epilepsy in a tertiary care hospital in India
- Conditions
- Health Condition 1: null- Persons clinically diagnosed with epilepsy of either gender and 18 years of age, receiving conventional and newer antiepileptic drugs (AEDs) as monotherapy or polytherapy for at least 6 months
- Registration Number
- CTRI/2018/02/012228
- Lead Sponsor
- ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 349
1. Subject clinically diagnosed with epilepsy,
2. Subject of either gender; 18 to 55 years of age
3. Subjects were in the interictal period or at least 12 h seizure free from sampling time.
4. Subjects receiving AEDs (valproic acid, carbamazepine, phenytoin, levetiracetam, lamotrigine, clobazam) for at least 6 months either as monotherapy or polytherapy
1. Subjects receiving other than above mentioned antiepileptic medications
2. Subjects receiving dietary/trace element supplements (excluding calcium or folic acid supplement)
3. Subjects having signs of malnutrition
4. Subjects with dietary restrictions due to a concomitant diagnoses.
5. Subjects with abnormal neurologic examination findings, intellectual disability and progressive brain disease.
6. Subjects with serious co-morbidities-including severe cardiac, renal, pulmonary, hepatic or other systemic disease or cancer.
7. Failure or unwillingness to provide informed consent
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method