A pilot study investigating the impact of micronutrients on children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Not Applicable

Completed

• Conditions: ADHD; Mental Health - Other mental health disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12612000645853
• 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: 2012-06-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

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).

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 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.

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)[Every visit (once every two weeks) through out the 24 week trial period and follow up];ADHD rating scales[Conners Parent and Teacher Rating Scales completed at switch points and a short version completed every two weeks throughout the 24 week trial period and at follow up];Strengths and Difficulties Questionnaire (SDQ) is a brief screening questionnaire for child mental health problems that is suitable for parents and teachers to fill out[Switch points of ABAB design as well as baseline]