Micronutrients and traumatic brain injury: a feasibility study

Not Applicable

Recruiting

• Conditions: Emotion dysregulation; Traumatic Brain Injury; Mental Health - Anxiety; Mental Health - Depression; Mental Health - Other mental health disorders; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12619001216101
• Lead Sponsor: niversity of Canterbury Foundation- donations given to the principal investigator

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-02
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

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

Inclusion Criteria

1) Between 6 and 13 years, 2) must be children or young people with a Traumatic Brain Injury more than a year old, and 3) meet the criteria for emotional dysregulation as defined by the Affective Reactivity Scale. Participants will be assessed on the ARI- P (parent scale). Those scoring more than 3 will be considered eligible.

Exclusion Criteria

1) A known allergy to any of the ingredient used in the intervention, 2) any known abnormality of mineral metabolism (e.g., Wilson's disease, haemochromatosis – assessed via blood tests), 3) ingestion of any medications with primarily central nervous system activity, including mood stabilizers, atomoxetine or stimulants. Participants must have been off their medications for a minimum of four weeks prior to the trial. Participants will not be encouraged to come off their medications in order to participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Affective Reactivity Index (ARI) will be used to measure feelings, behaviours and impairment specific to irritability.[Baseline (week 0), baseline (week 2), once a month for the 6 months of the intervention, 6- months post intervention]