Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 20, 2024

Primary Completion Date

January 1, 2026

Study Completion Date

January 1, 2026

Conditions
Modified Atkins DietAutism Spectrum DisorderStandard of Care
Interventions
DIETARY_SUPPLEMENT

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.

OTHER

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 Listed Sponsors
lead

All India Institute of Medical Sciences

OTHER

NCT06315465 - Efficacy of MAD as add-on Therapy in Comparison With Standard of Care in Children With ASD | Biotech Hunter | Biotech Hunter