A pilot study investigating the effect of micronutrients on anxiety and stress in children.

Not Applicable

Completed

• Conditions: anxiety; stress; Mental Health - Anxiety; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12612000671864
• Lead Sponsor: Department of Psychology, University of Canterbury

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-06-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Clinical Global Impressions Severity (CGI-S) and Improvement (CGI-I) Scales which are clinician rated questions assessing the severity of the illness (e.g., mild, moderate, severe) and any changes that have occurred since the last visit (e.g. no change, much improved, very much improved)[baseline and every two weeks of the trial and 3 month follow up];Screen for Child Anxiety Related Emotional Disorders (SCARED, (Birmaher et al., 1999): parent and self-report measures of a broad range of anxiety symptoms in youth.[baseline and every two weeks of the trial and 3 month follow up];cortisol levels (morning and evening) assessed via saliva[baseline and 8 weeks]