Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism.
Internet-based, randomized, controlled trial of omega-3 fatty acids for hyperactivity in autism.
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DOI：
10.1016/j.jaac.2014.01.018
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发表时间：
2014-06
影响因子：
13.3
通讯作者：
Law, Paul
中科院分区：
文献类型：
--
作者：
Bent, Stephen;Hendren, Robert L.;Zandi, Tara;Law, Kiely;Choi, Jae-Eun;Widjaja, Felicia;Kalb, Luther;Nestle, Jay;Law, Paul
初步证据表明，ω-3脂肪酸可以减少自闭症谱系障碍（ASD）儿童的多动症。我们试图研究一种新的基于互联网的临床试验设计的可行性，以评估这种补充剂的疗效。向参加互动自闭症网络的5-8岁儿童的父母发送了电子邮件邀请。所有研究程序，包括筛选、知情同意和结局指标的收集均通过互联网进行。主要的结果测量是父母和老师评定的异常行为检查表上多动的变化。在为期6周的招募期间，来自28个州的57名儿童符合所有资格标准，并被随机分配到每天1.3克omega-3脂肪酸或相同的安慰剂，持续6周。结果评估获得了所有57名参与者和57名教师，研究在3个月内完成。与安慰剂组（-2.6分）相比，omega-3脂肪酸组的儿童多动减少（-5.3分）更大，但差异无统计学意义（omega-3组改善1.9分，95% CI -2.2至5.2）。副作用很罕见，与omega-3脂肪酸无关。与会者的反馈是积极的。基于互联网的ASD儿童治疗的随机对照试验是可行的，可能会导致完成试验的时间和成本显着减少。需要更大的样本量来确定omega-3脂肪酸的功效。临床试验注册信息-Omega-3脂肪酸用于自闭症谱系障碍的多动症治疗; http://clinicaltrials.gov; NCT 01694667。
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. E-mail invitations were sent to parents of children aged 5-8 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. 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). Side effects were rare and not associated with omega-3 fatty acids. Participant feedback was positive. 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.
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DOI：
10.1097/00001648-199001000-00010
发表时间：
1990-01-01
期刊：
Epidemiology (Cambridge, Mass.)
影响因子：
--
作者：
Rothman, K J
通讯作者：
Rothman, K J
影响因子：
--
作者：
King, Bryan H.;Hollander, Eric;Sikich, Linmarie;McCracken, James T.;Scahill, Lawrence;Bregman, Joel D.;Donnelly, Craig L.;Anagnostou, Evdokia;Dukes, Kimberly;Sullivan, Lisa;Hirtz, Deborah;Wagner, Ann;Ritz, Louise
通讯作者：
Ritz, Louise
影响因子：
--
作者：
Amminger, G. Paul;Schafer, Miriam R.;Berger, Gregor E.
通讯作者：
Berger, Gregor E.
影响因子：
1.6
作者：
Jacobs, BP;Bent, S;Cummings, SR
通讯作者：
Cummings, SR
影响因子：
8
作者：
Shea, S;Turgay, A;Dunbar, F
通讯作者：
Dunbar, F