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
Conditions
Interventions
None listed
Sponsors
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate and compare serum levels of trace elements (Aluminium, cadmium, cobalt, copper, iron, manganese, nickel, lead, selenium and zinc) and electrolytes (sodium, potassium, calcium, magnesium and phosphate) in adult persons with epilepsy receiving monotherapy of conventional antiepileptic drugs (valproic acid, carbamazepine or phenytoin) or newer antiepileptic drugs (levetiracetam, lamotrigine or clobazam) and healthy volunteersTimepoint: At the time of enrollment | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare trace element and electrolytes status in adult persons with epilepsy on only conventional AEDs, only newer AEDs or combination of conventional and newer AEDs and age and gender matched healthy volunteer controlsTimepoint: At the time of enrollment;To estimate hepatic and renal function status in the above subjectsTimepoint: At the time of enrollment | — |
Countries
India
Contacts
Public ContactDr Sudhir Chandra Sarangi
Department of Pharmacology All India Institute of Medical Sciences New Delhi
Outcome results
None listed