Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Oral Folinic acid: Participants in one arm will receive Folinic acid orally at a dose of 2 mg/kg/day (or maximum 50 mg/day) and participants in other arm will receive a placebo formulat
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Satisfying DSM V criteria for autism 2. Unchanged antipsychotic medication, complementary, traditional, behavioral and education therapy 8 weeks prior to enrollment 3. Intention to maintain ongoing therapies constant throughout the trial
Exclusion criteria
Exclusion criteria: 1. Uncontrolled gastroesophageal reflux 2. History of liver or kidney disease; 3. Receiving drugs known to affect folate metabolism 4.Well-defined genetic syndromes or genetic mutations known to significantly affect folate-associated pathways; 5. A clinical seizure within the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Childhood Autism Rating Scale (CARS)Timepoint: At 0 week and after 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Childhood Sleep Habits QuestionnaireTimepoint: At 0 weeks and after 24 weeks | — |
Countries
India
Contacts
Public ContactPrateek Kumar Panda
AIIMS, Rishikesh
Outcome results
None listed