A Placebo-Controlled Pilot Exploration of Cholesterol Supplementation for Autistic Symptoms in Children with Low Cholesterol

AbstractThis pilot placebo-controlled trial (NCT00965068, 07/28/2009) explored effects of cholesterol supplementation on autism spectrum disorder (ASD) symptoms in children with abnormally low cholesterol. Fifteen children age 4 –12 with ASD and cholesterol<5th percentile for age/sex were randomized to 225  mg cholesterol vs. matched placebo twice daily for 12 weeks, followed by 12-week open extension. The cholesterol daily dose approximated the amount in two eggs. Measures included the Ohio Autism Clinical Impression Scale (OACIS, primary outcome), and Peabody Picture Vocabulary Test (PPVT-4). Effe ct sizes were emphasized over statistical tests. On the OACIS-Improvement score for overall ASD symptoms, both groups improved, with cholesterol showing nominally (nonsignificantly) more improvement. The cholesterol group improved more than placebo by medium to large effects in OACIS-I nonverbal com munication (d = −0.643); and OACIS-I problems with anxiety and fear (d = −0.671). Moreover, cholesterol showed significantly more improvement than placebo in PPVT-4 receptive language (p = 0.040). During the 12-week open extension, children originally assigned placebo improved significantly more in OACIS-I social interaction (p = 0.026, d = 1.170) from end of randomized phase than those receiving cholesterol throughout and improved more by large effects in OACIS-I aberrant behavior (d = 0.924), and anxiety/fear (d = 0.925). Graphs suggest continue...
Source: Journal of Developmental and Physical Disabilities - Category: Disability Source Type: research