Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome
Ketogenic Diet, West Syndrome, Infantile Spasm
About this trial
This is an interventional treatment trial for Ketogenic Diet focused on measuring Ketogenic diet, West Syndrome, Infantile Spasm, ACTH
Eligibility Criteria
Inclusion Criteria:
- Children, aged 6 month - 2 years with electroclinical diagnosis of west syndrome
Exclusion Criteria:
- Already on ACTH, prednisolone vigabatrin or KD therapy > 5days
- Tuberous sclerosis
- Vitamin trial responsiveness
- Known Pre-existing contraindications for KD (IEM, Porphyria etc.)
- Chronic systemic illness (Ex: Chronic kidney disease, congenital heart diseases etc)
Sites / Locations
- All India Institute of Medical SciencesRecruiting
- AIIMSRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ketogenic diet arm
ACTH arm
Children who have consented to the study and have been randomised to ketogenic diet arm will get ketogenic diet under supervision while starting with rapid hiking of lipid to carbohydrate ratio and primary response will be assessed at 6 weeks. Ketogenic diet ratio will be hiked quickly upto a maximum of 4:!. The duration of ketogenic diet can be extended beyond the period of study based on response and parental choice. A minimum period of 6 weeks of diet therapy will be undertaken baring any undue adverse effects when the primary outcome will be assessed
ACTH is the current standard therapy for children with west syndrome. Those who have been randomised to this arm will be started on high dose ACTH for 2 weeks followed by gradual tapering over remaining 4 weeks and primary response documented at 6 weeks of therapy. The high dose ACTh is 150U/m2 or 6U/kg dose administered IM daily for two weeks. After this the doses will be tapered gradually and ACTH will be stopped by 4 weeks for a total treatment duration of strictly 6 weeks.