Investigation into the effect of a nutritional supplement on ADHD symptoms in a clinical sample of children with Attention-Deficit/Hyperactivity Disorder (ADHD): a double blind randomized placebo controlled trial with open label extension.

niversity of Canterbury0 sites93 target enrollmentAugust 12, 2013

Overview

No summary available.

Registry

who.int

Start Date

August 12, 2013

End Date

January 1, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Canterbury

•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).

•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.