None listed
Conditions
Brief summary
A New Zealand Health Survey (He Ara Oranga) revealed a growing number of adolescents in NZ struggling with mental health issues, with among the worst youth suicide rate in the OECD. Insufficient available resources and barriers such as stigma, finances and time contribute to this crisis. New treatment options need to be explored urgently. One option is to study the effects of nutrient interventions on mental health given the growing association between poor diet and poor mental health problems in adolescents and known effects of micronutrients on optimizing brain metabolism. Research over a decade has demonstrated efficacy in using micronutrients to treat psychiatric symptoms, ranging from emotional dysregulation and aggression to trauma and stress. More recently, we have established effective remote monitoring of adults taking micronutrients or placebo via an online GP referral system with low drop out and excellent acceptability. This current study aims to extend to 150 youth (12-17 years) struggling with emotional dysregulation, using gold standard methodology (RCT), working with GPs, schools and parents for referrals. We need to assess interventions that are scalable, with good reach and affordable. A nutritional intervention delivered remotely presents as an acceptable and scalable method for both teenagers and whanau that has the potential to effectively improve mental health for many young people.
Interventions
Micronutrient formula
Participants will be randomly assigned to receive either a micronutrient formula or a placebo for eight weeks. After eight weeks, all participants will enter into an open-label phase whereby all participants can choose to take the micronutrient formula for another eight weeks. Both the micronutrient formula and the placebo are in capsule form and are to be taken orally at a dose of 12 capsules per day; four capsules taken three times per day with food and water. The micronu
Micronutrient formula Participants will be randomly assigned to receive either a micronutrient formula or a placebo for eight weeks. After eight weeks, all participants will enter into an open-label phase whereby all participants can choose to take the micronutrient formula for another eight weeks. Both the micronutrient formula and the placebo are in capsule form and are to be taken orally at a dose of 12 capsules per day; four capsules taken three times per day with food and water. 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), 1,728mcg; Vitamin C (as ascorbic acid), 600 mg; Vitamin D (as cholecalciferol), 72mcg; Vitamin E (as d-alpha tocopheryl succinate), 194.4mg; Vitamin K (75% as phylloquinone; 25% as menaquinone-7), 120 mcg; Thiamin (as thiamin HCI), 60 mg; Riboflavin, 18 mg; Niacin (as niacinamide, nicotinamide riboside CI, & nicotinic acid), 144 mg; Vitamin B6 (as pyridoxine HCI & pyridoxal-5-hosphate), 60 mg; Folate (as calcium folinate & L-methylfolate calcium), 1,500 mcg DFE; Vitamin B12 (as hydroxo-, adenosyl-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 (from Atlantic kelp), 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: Alpha-lipoic acid, Great Salt Lake minerals, Inositol, Acetyl-L-carnitine HCI, Atlantic kelp (laminaria digitata), grape seed extract, Ginkgo biloba leaf extract, L-methionine, N-acetyl-L-cysteine, mixed tocopherols (organic), mixed tocotrienols (from palm fruit), trace minerals as NutraTek chelation complex, Boron, Vanadium, Nickel. Other ingredients: Vegetarian capsule (hypromellose), microcrystalline cellulose, magnesium stearate, silicon dioxide, titanium dioxide. Adherence to the intervention will be assessed weekly throughout the study period. Participants are required to report the number of capsules missed over a weekly period and photograph unused or missed capsules, submitting photos to the study website.
Sponsors
Professor Julia Rucklidge
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1) between 12 and 17 years, 2) regular access to the internet/phone, 3) living in New Zealand, 4) considered reliable and compliant with protocol (including ingestion of as many as 12 capsules/day with food), 5) be presenting to their GP or school counsellor with functionally impairing emotional dysregulation which cannot be better accounted for by a medical condition or parental identified as showing disabling emotions that are interfering with their ability to function, 6) sufficient ability to read and write English in order to complete questionnaires, 7) be attending primary or high school, and 8) receive a CGI-S rating of at least 4 (moderately ill) on screening and a minimum score of 10 on the Emotion Dysregulation Inventory or 3 on the Affective Reactivity Index.
Exclusion criteria
1) The main strict contraindications are metabolic conditions such as Wilson’s disease (copper), haemochromatosis (iron), phenylketonuira (phenylalanine) and trimethylaminuria (choline), 2) Known neurological disorders involving brain or other central function (e.g., previously diagnosed intellectual disability, autism spectrum disorder, epilepsy, MS, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder with associated suicidality, substance dependence or psychosis), 3) pregnant or breastfeeding, and 4) Any medications with primarily central nervous system activity, including psychotropic medication (e.g. SSRIs, tricyclics, benzodiazepines). Participants must have been off these medications for a minimum of four weeks prior to the trial. Participants will not be encouraged to come off a medication in order to participate.
Outcome results
None listed