80
Participants
Start Date
March 20, 2024
Primary Completion Date
January 1, 2026
Study Completion Date
January 1, 2026
Modified Atkin's Diet with standard of care
children who have given their consent and are randomized into Group I arm receives Modified Atkins Diet along with standard of care after completion of baseline investigations. Modified Atkin's Diet will be started in ratio of 1:1 and compliance is monitored by urine ketones. Followup will be done telephonically to check for compliance , adverse events at every 4 week intervals till 24 weeks.
Standard of Care
Standard of care intervention plan will be devised for each subject which includes Behavioral therapy , Psychoeducation, Activity based interventions like attention enhancement exercises, self help skills, Occupational therapy, Pharmacotherapy, Sensory integration therapy. The parents of the children will be called telephonically every weekly to check for any issues and reinforcement to ensure appropriate regular behavioral intervention to be provided to the child. Physical follow up will be done every 4 weekly till 24 weeks.
All India Institute of Medical Sciences
OTHER