A randomized controlled trial investigating the efficacy and safety of a micronutrient formula in the treatment of Attention-Deficit/Hyperactivity Disorder in childre

Not Applicable

Completed

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

• Registration Number: ACTRN12613000896774
• Lead Sponsor: niversity of Canterbury

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-12
• Study Completion: 2018-01-01
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

1) between 7 and 12 years, 2) considered reliable and compliant with the protocol (including the ingestion of as many as 12 capsules/day with food), and 3) meet criteria for ADHD as assessed by the K-SADS, and the Conners Rating Scales (T score greater than 65 on both parent and teacher form for any of the ADHD DSM-IV subscales).
A subset (n=20) of children (males with Combined ADHD) will be asked to participate in an 1H-MRS pilot study in order to begin documenting the impact that nutrition has on the brains of ADHD children. Those participants must be compatible with the imaging scanner (i.e. no braces, no history of claustrophobia).

Exclusion Criteria

1) Neurological disorder involving brain or other central function (e.g., intellectual disability as assessed by the Wechsler Intelligence Scale for Children, autism spectrum disorder, epilepsy, MS, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder or psychosis), 2) Any serious medical condition, 3) Any patient known to be allergic to the ingredients of the intervention, 4) Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 5) Any other medication with primarily central nervous system activity, including stimulants. Participants must have been off of these medications for a minimum of four weeks prior to the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ADHD Rating Scale -IV (clinician) [baseline, 10 weeks (end of RCT), 20 weeks (end of open-label), 6 and 12 months post-trial ];Clinician Clinical Global Impression (CGI)[every two weeks during the trial, 10 weeks (end of RCT), every two weeks during the open label phase, 20 weeks (end of open-label), 6 and 12 months post-trial. Data collected bimonthly (ie between asssessment phases) will only be used if there is a dropout or a withdrawal. ];Conners Parent Rating Scale Long Version (CPRS-R:L) - the DSM-IV Inattentive, DSM-IV Hyperactive-Impulsive and DSM-IV:Total subscales. [baseline, 10 weeks (end of RCT), 20 weeks (end of open-label), 6 and 12 months post-trial. <br>At bimonthly intervals the ADHD Rating Scale IV will be administered and only used in the case of dropouts or withdrawals from the study. The ADHD Rating Scale IV contains the exact same items as the DSM-IV Inattentive and DSM-IV Hyperactive-Impulsive subscales of the CPRS-R:L.]