Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism
Bent S, Hendren RL, Zandi T, Law K, Choi JE, Widjaja F, Kalb L, Nestle J, Law P
Journal of the American Academy of Child and Adolescent Psychiatry · 78 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute of Mental Health
- Gobierno
- National Center for Research Resources
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NIMH NIH HHS
- Gobierno
- NCRR NIH HHS
- Gobierno
- NCATS NIH HHS
- Subvenciones
- National Center for Research Resources (UL1RR024131); National Institute of Mental Health (T32MH019545); National Center for Advancing Translational Sciences (UL1TR000004)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2014-03-14 · J Am Acad Child Adolesc Psychiatry · vol. 53 · número 6 · págs. 658–666
- Editorial
- Elsevier BV
- Citado
- 112 citas · más que el 97% de estudios similares · 7.3× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Fatty Acid Research and Health · Autism Spectrum Disorder Research · Child Nutrition and Feeding Issues
- Palabras clave
- omega-3 fatty acids, autism spectrum disorder, hyperactivity, dietary supplementation, trial feasibility, Aberrant Behavior Checklist, children, parent and teacher ratings, adverse events
- MeSH
- humans, hyperkinesis, fatty acids, omega-3, treatment outcome, double-blind method, child development disorders, pervasive, internet, child, child, preschool, female, male
9 autores
- Stephen Bent🇺🇸 · autor de correspondenciaUniversity of California, San Francisco
- Robert L. Hendren🇺🇸University of California, San Francisco
- Tara Zandi🇺🇸Kennedy Krieger Institute
- Kiely Law🇺🇸Kennedy Krieger Institute
- Jae‐Eun Choi🇺🇸University of California, San Francisco
- Felicia Widjaja🇺🇸University of California, San Francisco
- Luther G. Kalb🇺🇸Kennedy Krieger Institute
- Jay Nestle🇺🇸Kennedy Krieger Institute
- Paul A. Law🇺🇸Kennedy Krieger Institute
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
Preliminary evidence suggests that omega-3 fatty acids may reduce hyperactivity in children with autism spectrum disorder (ASD). We sought to examine the feasibility of a novel, Internet-based clinical trial design to evaluate the efficacy of this supplement.
Method
E-mail invitations were sent to parents of children aged 5 to 8 years enrolled in the Interactive Autism Network. All study procedures, including screening, informed consent, and collection of outcome measures took place over the Internet. The primary outcome measures were parent- and teacher-rated changes in hyperactivity on the Aberrant Behavior Checklist (ABC-H).
Results
During the 6-week recruitment period, 57 children from 28 states satisfied all eligibility criteria and were randomly assigned to 1.3 grams of omega-3 fatty acids or an identical placebo daily for 6 weeks. Outcome assessments were obtained from all 57 participants and 57 teachers, and the study was completed in 3 months. Children in the omega-3 fatty acid group had a greater reduction in hyperactivity (-5.3 points) compared to the placebo group (-2.6 points), but the difference was not statistically significant (1.9-point greater improvement in the omega-3 group, 95% CI = -2.2 to 5.2). Adverse events were rare and not associated with omega-3 fatty acids. Participant feedback was positive.
Conclusion
Internet-based, randomized controlled trials of therapies in children with ASD are feasible and may lead to marked reductions in the time and cost of completing trials. A larger sample size is required to definitively determine the efficacy of omega-3 fatty acids. Clinical trial registration information-Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder; http://clinicaltrials.gov; NCT01694667.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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