2.1. Patients and Study Design
DSM-5, autism
SECONDARY, ADVERSE EVENT, SEIZURE DISORDER, COLD, CHRONIC DISEASE
Children aged 3–7 years with a confirmed clinical diagnosis of ASD that was reconfirmed based upon the DSM-5 symptom checklist were enrolled in this double-blind prospective study. Inclusion criteria were an ASD diagnosis, no prior use of sulforaphane-containing supplements, completion of all follow-ups, and a parent/caregiver willing to consent. Exclusion criteria involved proven genetic diagnosis (secondary autism), seizure disorder, chronic disease, and medication affecting testing.The study comprised three visits. The first visit included screening, randomization, and the start of treatment. Two follow-ups were performed at 18 and 36 weeks after the first visit. At each visit, the medical history, physical examination including vital signs, blood samples, adverse event reporting, and SRS-2, ABC, and ADOS-2 scores were obtained. Treatment was discontinued after the 36-week visit. The study was carried out in a randomized, double-blind, placebo-controlled manner. Parents/caregivers were then informed whether their child received sulforaphane or placebo.SFN was administered orally once a day. The subjects were dosed uniformly with 50 µmol SFN per day. Parents/caregivers were instructed to mix the content of one PE/AL bag (1.2 g of the treatment) with a small amount of cold water or other cold food (yogurt, fruit juice). The placebo group received an equivalent dose of spinach puree powder.