None listed
Conditions
Brief summary
Traumatic Brain Injury (TBI) is the leading cause of death and long- term disability in children and young adults worldwide. Currently, the incidence rate is estimated between 150 to 300 per 100,000 population per year. In New Zealand, the total incidence rate is 790 per 100,000 people per year and children and adolescents account for 70% of this number. Research shows that those numbers may be underestimated since only people who have sought treatment are likely to be included. Outcomes depend on many pre-TBI factors but most research found that personality changes and behavioural problems were common post injury TBI outcomes. The proposed research is a feasibility study investigating whether children with a Traumatic Brain Injury are able to adhere to a six months intervention of broad-spectrum micronutrient formula, to assess the safety and tolerability of a specific formulation, Daily Essential Nutrients, on this population and to observe if there are any changes in the children’s ability to manage their emotions. The study also aims to understand whether individual comorbid symptoms, determined during an initial interview with participants and families, vary during the intervention. Based on previous research, we expect those symptoms to be low mood, anxiety, sleep disturbances and ADHD.
Interventions
All participants will be receiving a micronutrient formula for 6 months. The micronutrient formula will be made available in capsule and powder form. Whether the participants take the formula in a capsule or powder form, or a combination of both, will depend on both their preference and whether or not they are able to swallow the capsules. Participants will be asked to ingest 9 capsules daily, three capsules, three times a day or the equivalent in powder form. It is recommended the micronutrien
All participants will be receiving a micronutrient formula for 6 months. The micronutrient formula will be made available in capsule and powder form. Whether the participants take the formula in a capsule or powder form, or a combination of both, will depend on both their preference and whether or not they are able to swallow the capsules. Participants will be asked to ingest 9 capsules daily, three capsules, three times a day or the equivalent in powder form. It is recommended the micronutrients are taken with food. The micronutrient intervention is a blend of vitamins, minerals, antioxidants and amino acids. The formula, Daily Essential Nutrients, is being manufactured and donated by Hardy Nutritionals (Registered Trademark), Canada and consists of the following ingredients. The following doses are for 12 capsules (full dose per day): Vitamin A (as retinyl palmitate), 5,760 IU; Vitamin C (as ascorbic acid), 600 mg; Vitamin D (as cholecalciferol), 3,000 IU; Vitamin E (as d-alpha tocopheryl succinate), 360 IU; Vitamin K (75% as phylloquinone; 25% as menaquinone-7), 120 mcg; Thiamin (as thiamin mononitrate), 60 mg; Riboflavin, 18 mg; Niacin (as niacinamide), 90 mg; Vitamin B6 (as pyridoxine hydrochloride), 69.9 mg; Folate (as L-methylfolate calcium), 801 mcg; Vitamin B12 (as methylcobalamin), 900 mcg; Biotin, 1080 mcg; Pantothenic acid (as d-calcium pantothenate), 30 mg; Calcium (as chelate), 1,320 mg; Iron (as chelate), 13.8 mg; Phosphorus (as chelate), 840 mg; Iodine (as chelate), 204 mcg; Magnesium (as chelate), 600 mg; Zinc (as chelate), 48 mg; Selenium (as chelate), 204 mcg; Copper (as chelate), 7.2 mg; Manganese (as chelate), 9.6 mg; Chromium (as chelate), 624 mcg; Molybdenum (as chelate), 144 mcg; Potassium (as chelate), 240 mg. Proprietary blend: Choline bitartrate, Alpha-lipoic acid, Mineral wax, Inositol, Acetyl-L-carnitine, Grape seed extract, Ginkgo biloba leaf extract, L-methionine, N-acetyl-L-cysteine, Boron, Vanadium, Lithium orotate, Nickel. Other ingredients: Vegetarian capsule (hypromellose), microcrystalline cellulose, magnesium stearate, silicon dioxide, titanium dioxide. Adherence to the intervention will be assessed monthly through pill taking records kept by the participants.
Sponsors
University of Canterbury Foundation- donations given to the principal investigator
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
6 Years to 13 Years
Healthy volunteers
No
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.
Outcome results
None listed