Ketogenic Diet vs ACTH for the Treatment of Children With West Syndrome

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 18, 2022

Primary Completion Date

July 31, 2024

Study Completion Date

July 28, 2024

Conditions
Ketogenic DietWest SyndromeInfantile SpasmACTH
Interventions
DIETARY_SUPPLEMENT

Ketogenic diet

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

DRUG

ACTH

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.

Trial Locations (2)

110029

All India Institute of Medical Sciences, New Delhi

110049

AIIMS, New Delhi

All Listed Sponsors
lead

All India Institute of Medical Sciences

OTHER