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30 June 2014. Researchers at University of California in San Francisco and Kennedy Krieger Institute in Baltimore completed a clinical trial conducted entirely online testing the ability of omega-3 fatty acids to control hyperactivity in children with autism. The team led by UC-San Francisco medical professor Stephen Bent published its findings in this month’s issue of Journal of the American Academy of Child & Adolescent Psychiatry (paid subscription required).
The intermediate-stage trial was designed to test the effects of omega-3 fatty acids on hyperactivity of children, age 5 to 8, diagnosed with autism. Omega-3 fatty acids are considered essential nutrients for many bodily functions, such as normal blood clotting and building cell membranes in the brain. The body does not make omega-3 fatty acids on it own, thus they’re provided in food.
Early, preclinical evidence shows a link between omega-3 fatty acids and symptoms of attention deficit/hyperactivity disorder, or ADHD. This trial tested that association among children with autism. Half of the sample of 57 children, selected at random, were given a daily pudding packet with 1.3 grams of omega-3 fatty acids for 6 weeks, while the other half of the sample received an identically flavored placebo with safflower oil.
The trial looked primarily for changes in hyperactivity, measured by a series of 16 items from a larger 58-item aberrant behavior checklist. The researchers measured other symptoms as well, such as lethargy, irritability, and inappropriate speech.
The 57 children from 28 states in the U.S. taking part in the trial were recruited in about 6 weeks from the Interactive Autism Network, an online community of parents of children with autism hosted by Kennedy Krieger Institute. The parents were alerted of the study and recruited by e-mail, with all screening, informed consent, and outcome measures conducted over the Internet. Screening was accomplished with a short questionnaire completed by parents that verified their children received a professional diagnosis of autism, which eliminated the need for children and parents making a preliminary clinical visit.
Both the children’s parents and teachers completed the behavior questionnaire items online, which captured the data immediately in a database. The results show children taking omega-3 fatty acids with lower hyperactivity scores than the comparable group taking a placebo, but the differences were not large enough to be statistically reliable.
Despite the the lack of unambiguous results, the researchers were pleased with conduct of an online clinical trial. “The entire study was completed in slightly more than three months from the start of enrollment,” says Bent in a university statement, “and demonstrates there are many advantages including low cost, rapid enrollment, high completion rate, convenience for participating families, and the ability to participate from virtually any location.”
Bent adds that the researchers received 100 percent completion of the outcome measures from parents and teachers, which he says engages parents at a higher rate than in traditional clinical trials.
Read more:
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- Biotech Group Issues Clinical Trial Data Sharing Guidelines
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