COMPARISON OF BODY WEIGHT, FAT AND TOTAL WATER CONTENT IN PERSONS WITH EPILEPSY ON LONG TERM TREATMENT WITH CONVENTIONAL AND NEWER ANTIEPILEPTIC DRUGS

COMPARISON OF BODY COMPOSITION IN PERSONS WITH EPILEPSY RECEIVING CHRONIC THERAPY WITH CONVENTIONAL AND NEWER ANTIEPILEPTIC DRUGS

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/05/003701

Enrollment

Registered

2013-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Persons with epilepsy, more than 18 years of age, either sex, on treatment with conventional and/or newer antiepileptic drugs (AEDs) as monotherapy or polytherapy for at least 6 months

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Ambulatory persons clinically diagnosed with epilepsy 2. Subjects were in the interictal period or at least 12 h seizure free from sampling time 3. Either male or female and 18 to 55 years of age 4. Receiving conventional and/or newer antiepileptic drugs (AEDs) as monotherapy or polytherapy for at least 6 months (i) Valproic acid (ii) Carbamazepine (iii) Phenytoin (iv) Levetiracetam (v) Lamotrigine (vi) Clobazam

Exclusion criteria

Exclusion criteria: b. Subjects receiving dietary/trace element supplements (excluding calcium or folic acid supplement) c. Subjects having signs of malnutrition d. Subjects with dietary restrictions due to a concomitant diagnoses. e. Subjects with abnormal neurologic examination findings, intellectual disability and progressive brain disease. f. Subjects with serious co-morbidities-including severe cardiac, renal, pulmonary, hepatic or other systemic disease or cancer. g. Failure or unwillingness to provide informed consent

Design outcomes

Primary

Measure	Time frame
To compare body composition [body fat mass, body fat mass, lean dry mass, total body water (TBW), intra-cellular water (ICW), extra-cellular water (ECW) and basal metabolic rate (BMR)] and anthropometric parameters (height, body weight and body mass index) in adult persons with epilepsy receiving monotherapy of conventional antiepileptic drugs (AEDs) (valproic acid, carbamazepine or phenytoin) or newer AEDs (levetiracetam, lamotrigine and clobazam) and healthy volunteersTimepoint: At enrollment time	—

Measure

Time frame

To compare body composition [body fat mass, body fat mass, lean dry mass, total body water (TBW), intra-cellular water (ICW), extra-cellular water (ECW) and basal metabolic rate (BMR)] and anthropometric parameters (height, body weight and body mass index) in adult persons with epilepsy receiving monotherapy of conventional antiepileptic drugs (AEDs) (valproic acid, carbamazepine or phenytoin) or newer AEDs (levetiracetam, lamotrigine and clobazam) and healthy volunteersTimepoint: At enrollment time

—

Secondary

Measure	Time frame
To compare body composition and anthropometric parameters 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 enrollment time;To estimate lipid profile, blood glucose, hepatic and renal function status in the above subjectsTimepoint: At enrollment time	—

Countries

India

Contacts

Public ContactDr Sudhir Chandra Sarangi

Department of Pharmacology All India Institute of Medical Sciences New Delhi

scsarangi@gmail.com

Outcome results