None listed
Conditions
Brief summary
Anxiety and depression in adults are highly prevalent and impairing health conditions in New Zealand. The cost to the New Zealand health system and society in treating these difficulties is great. Current best evidence treatment for mental health issues includes medication and psychotherapy. Whilst fairly accessible via prescriptions, medication for mental health can have a range of side effects such as weight gain, agitation and loss of libido. Although avoiding these side effects, psychotherapy can be difficult to access in the community due to cost and limited resources. In addition, both psychotropic medication and psychotherapy do not work for all individuals experiencing anxiety and depression. Research has indicated that micronutrients (vitamins and minerals) play an important role in mental health and that administration of micronutrients over and above what can be ingested by diet alone can assist in improving mood liability, improve concentration, stress, general anxiety, and low mood. Research using micronutrients as a treatment for mental health issues has provided a reassuring safety profile. There have been few well controlled trials investigating the effect of micronutrients specifically on anxiety and depression in adults, in particular in the community. This trial aims to randomly assign participants to receive either micronutrients or placebo and measure the impact micronutrients have on anxiety and depression.
Interventions
Micronutrient formula
Participants will be randomly assigned to receive either a micronutrient formula or a placebo for ten weeks. After ten weeks, all participants will enter into an open-label phase whereby all participants can choose to take the micronutrient formula for another 10 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
Micronutrient formula Participants will be randomly assigned to receive either a micronutrient formula or a placebo for ten weeks. After ten weeks, all participants will enter into an open-label phase whereby all participants can choose to take the micronutrient formula for another 10 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), 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 weekly throughout the study period. Participants are required to report the number of capsules missed over a two or four week 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, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1) between 18 and 65 years, 2) regular access to the internet, 3) considered reliable and compliant with the protocol (including the ingestion of as many as 12 capsules/day with food), 4) be proficient in comprehension of written and spoken English language and 5) and be presenting to their general practitioner (GP) with functionally impairing anxiety or depressive symptoms which cannot be better accounted for by a medical condition.
Exclusion criteria
1) The main strict contraindications are metabolic conditions such as Wilson’s disease (copper), haemochromatosis (iron), phenylketonuira (phenylalanine) and trimethylaminuria (choline). 2) Neurological disorders involving brain or other central function (e.g., 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) Any serious medical condition, 4) Any patient known to be allergic to the ingredients of the intervention, 5) Any other medication with primarily central nervous system activity, including psychotropic medication (e.g. SSRIs, tricyclics, benzodiazepines). Participants must have been off of these medications for a minimum of four weeks prior to the trial. Participants are not encouraged to come off of a medication in order to participate in the trial. 6) Women who are pregnant or breastfeeding.
Outcome results
None listed