Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability.
Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability.
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DOI：
10.1016/j.nutres.2013.08.005
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发表时间：
2013-11
期刊：
影响因子：
--
通讯作者：
Georgieff MK
中科院分区：
文献类型：
--
作者：
Wozniak JR;Fuglestad AJ;Eckerle JK;Kroupina MG;Miller NC;Boys CJ;Brearley AM;Fink BA;Hoecker HL;Zeisel SH;Georgieff MK
对于胎儿酒精谱系障碍 (FASD)、与身体异常、脑损伤和神经认知异常相关的终生疾病，尚无生物治疗方法。在临床前研究中，胆碱可以部分改善产前酒精暴露造成的记忆和学习缺陷。这项 I 期试点研究评估了 FASD 儿童补充胆碱的可行性、耐受性和潜在副作用。我们假设胆碱具有良好的耐受性，且不良事件最少。该研究设计是一项双盲、随机、安慰剂对照试验。参与者包括 20 名年龄 2.5-4.9 岁的儿童，他们有产前酒精暴露和 FASD 诊断。参与者被随机分配至 500 毫克。每天服用胆碱或安慰剂，持续九个月（10 次为活性药物；10 次为安慰剂）。主要结果指标包括可行性、耐受性、不良反应和血清胆碱水平。十七名参与者完成了这项研究。家长填写的记录表和剂量计数证明，依从性为 82-87%。定期 24 小时饮食回顾显示没有饮食混淆的证据。不良事件很少，并且在活性组和安慰剂组中是相同的，除了鱼腥味，这种气味仅发生在活性组中。研究参与者没有出现严重的不良事件。这项 I 期试点研究表明，2-5 岁儿童每天补充 500 毫克胆碱，持续九个月是可行的，并且具有很高的耐受性。目前正在进一步检查补充胆碱对 FASD 的疗效。
There are no biological treatments for fetal alcohol spectrum disorders (FASD), lifelong conditions associated with physical anomalies, brain damage, and neurocognitive abnormalities. In pre-clinical studies, choline partially ameliorates memory and learning deficits from prenatal alcohol exposure. This Phase I pilot study evaluated the feasibility, tolerability, and potential adverse effects of choline supplementation in children with FASD. We hypothesized that choline would be well-tolerated with minimal adverse events. The study design was a double-blind, randomized, placebo-controlled trial. Participants included 20 children, ages 2.5–4.9y, with prenatal alcohol exposure and FASD diagnoses. Participants were randomly assigned to 500 mg. choline or placebo daily for nine months (10 active; 10 placebo). Primary outcome measures included feasibility, tolerability, adverse effects, and serum choline levels. Seventeen participants completed the study. Compliance was 82–87% as evidenced by parent-completed logsheets and dose counts. Periodic 24-hour dietary recalls showed no evidence of dietary confounding. Adverse events were minimal and were equivalent in the active and placebo arms with the exception of fishy body odor, which occurred only in the active group. There were no serious adverse events to research participants. This Phase I pilot study demonstrates that choline supplementation at 500 mg per day for nine months in children ages 2–5 is feasible and has high tolerability. Further examination of the efficacy of choline supplementation in FASD is currently underway.
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影响因子：
4.8
作者：
Mellott, TJ;Williams, CL;Blusztajn, JK
通讯作者：
Blusztajn, JK
影响因子：
2.9
作者：
ABEL, EL
通讯作者：
ABEL, EL
影响因子：
2.9
作者：
Ryan SH;Williams JK;Thomas JD
通讯作者：
Thomas JD
影响因子：
2.5
作者：
Li, Q;Guo-Ross, S;Swartzwelder, HS
通讯作者：
Swartzwelder, HS
DOI：
10.1111/j.1530-0277.1998.tb05909.x
发表时间：
1998-12-01
期刊：
ALCOHOL-CLINICAL AND EXPERIMENTAL RESEARCH
影响因子：
--
作者：
Olson, HC;Feldman, JJ;Bookstein, FL
通讯作者：
Bookstein, FL