Sodium Chloride supplementation in reducing incidence of low sodium levels in children with epilepsy receiving Oxcarbazepine.
Not Applicable
- Conditions
- Health Condition 1: G400- Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
- Registration Number
- CTRI/2021/12/038388
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Children aged 1-18 years
2. Newly diagnosed with epilepsy (structural/non-structural)
Exclusion Criteria
1. Receiving any other ASM/other medications which interfere with
serum sodium and/or body water balance
2. Chronic renal, gastrointestinal, hepatic, pulmonary, cardiac or
endocrinal illness
3. IAP grade II or more PEM
4. Baseline hyponatremia/hypernatremia
5. Receiving intravenous fluid at the time of starting oxcarbazepine
6. Anorexia/Bulimia nervosa
7. Caregiver not providing informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of children with hyponatremia (serum sodium less than 135 <br/ ><br>meq/l) in both armsTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Change in behavioral co-morbidities (measured by CBCL) in both arms <br/ ><br>Timepoint: 12 weeks;Comparison of the frequency of each adverse event between both arms (CTCAE grading)Timepoint: 12 weeks;Short assessment of patient <br/ ><br>satisfaction score, clinical global impression-improvement, and efficacy index at the time of discharge in both armsTimepoint: 12 weeks;The change in SQ/IQ (SQ/Full-scale IQ obtained from <br/ ><br>VSMS/MISIC) of children in both <br/ ><br>armsTimepoint: 12 weeks;The proportion of children with <br/ ><br>symptomatic and severe hyponatremia in both armsTimepoint: 12 weeks;The proportion of children with seizure <br/ ><br>recurrence and requiring polytherapy in <br/ ><br>12 weeks after starting oxcarbazepine <br/ ><br>in both armsTimepoint: 12 weeks;To establish the causality of the adverse event by Naranjo probability score <br/ ><br>Timepoint: 12 weeks