ACTRN12612000645853已完成未知
Investigation into the effect of micronutrients on mood and behaviour in children with Attention-Deficit/Hyperactivity Disorder (ADHD): a study using single case ABAB design.
Department of Psychology, University of Canterbury0 个研究点目标入组 15 人开始时间: 2012年6月19日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 8 Years 至 12 Years（—）
- 性别
- All
入选标准
- •1.Participants are between 8-12 years of age.
- •2.Each participant must have a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of as many as 15 capsules/day).
- •3.Participants must be able to eat at least a snack three times per day, so that the capsules will not be ingested on an empty stomach.
- •4.Participants meet criteria for ADHD as assessed by the K-SADS (Kaufman, et al., 1997), the Conners Rating Scales (score greater than 70 on either parent or teacher form; (Conners, 1997).
排除标准
- •1.Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy). Purely peripheral neurological problems are not excluded (e.g., Raynaud’s, peripheral diabetic neuropathy).
- •2.Any serious medical condition for which major medical interventions are anticipated during the duration of the trial.
- •3.Any patient known to be allergic to the ingredients of the intervention (including ginkgo biloba, germanium sesquioxide, or grape seed) will be excluded.
- •4.Evidence of untreated or unstable thyroid disease (thyroid testing will occur at baseline).
- •5.Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis).
- •6.Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial.
- •7.Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks.
- •8.Any type of nutritional or herbal supplement, known to have a centrally-acting effect, will result in a patient's exclusion. However, patients who have been taking supplements such as echinacea, chondroitin, or glucosamine may enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continue on these agents throughout the study. We will permit people to take as much as 1 g/day of EPA and DHA combined.
- •9.Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
研究者
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