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临床试验/ACTRN12612000671864
ACTRN12612000671864已完成未知

A pilot investigation into the effect of micronutrients on anxiety and stress in Canterbury children: a multiple baseline 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22日最近更新:
适应症

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
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
8 Years 至 11 Years(—)
性别
All

入选标准

  • •1. Participants are between 8-11 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 8 capsules/day).
  • •3. Participants must be able to eat at least a snack two times per day, so that the capsules will not be ingested on an empty stomach.
  • •4. Participants meet criteria for elevated anxiety as assessed by the SCARED. They would also require a CGAS score of at least 50.

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 participant known to be allergic to the ingredients of the intervention (including ginkgo biloba, germanium sesquioxide, or grape seed) will be excluded.
  • •4. Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis).
  • •5. 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.
  • •6. Participants will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks.
  • •7. Any type of nutritional or herbal supplement, known to have a centrally-acting effect, will result in a participant's exclusion. However, participants 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.
  • •7. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.

研究者

发起方
Department of Psychology, University of Canterbury

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