Comparison of two high fat, low carbohydrate diets in controlling infantile spasms in children who do not respond to conventional medicines
Not Applicable
- Conditions
- Health Condition 1: G403- Generalized idiopathic epilepsy and epileptic syndromes
- Registration Number
- CTRI/2020/03/023791
- Lead Sponsor
- Jaya Shankar Kaushik
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Children aged 9 months to 5 years with Infantile spasm refractory to first line treatment.
Exclusion Criteria
(i) Children with known or suspected inborn error of metabolism.
(ii) Children with systemic illness-renal, pulmonary, cardiac or hepatic dysfunction.
(iii) Severe malnutrition (weight for length and height for age less than 3 SD for mean as per WHO growth charts).
(iv) Motivational and psychosocial issues in the family which could possibly affect the compliance.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children who achieved seizure freedom as per parental reports at 4 weeks and 12 weeks in both the groups.Timepoint: Proportion of children who achieved seizure freedom as per parental reports at 4 weeks and 12 weeks in both the groups.
- Secondary Outcome Measures
Name Time Method a. Proportion of children who achieved 50 percent reduction in seizure as per parental reports at 4 weeks and 12 weeks in both the groups. <br/ ><br>b. Proportion of children who achieve resolution of Hypsarrhythmia. <br/ ><br>c. Description and proportion of the adverse effects of the diet as per parental reports. <br/ ><br>Timepoint: 4 weeks <br/ ><br>12 weeks