Information for Participants and Self Referral

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Micronutrients: What is the evidence?

Research has investigated the role of nutrition in the development of mental health issues (Davidson & Kaplan, 2012a; O’Neil et al, 2014 ).

Individuals with poor mental health (hauora hinengaro) report nutrient-poor diets when compared to healthy controls (Robson & Gray, 2007; Davidson and Kaplan, 2012b).

More recent trials have demonstrated efficacy of multi-nutrients (taiora) in improving emotional regulation, reduce stress and improving attention/concentration and hyperactivity symptoms and improving insomnia with no adverse effects (Gariballa & Forster, 2007; Schlebusch et al, 2000; Rucklidge et al, 2014a; Popper, 2014; Lothian et al, 2016).

The safety profile of multi-nutrient treatment in adults (pakeke) and children (tamariki) is reassuring (Simpson et al, 2011, Rucklidge et al, 2014b; Rucklidge et al, 2019).

What is the trial?

To test the effectiveness of multi-nutrients on symptoms of anxiety (āwangawanga) and depression (mate pāpōuri) in adults NOT currently taking anti-depressant or anti-anxiety medications. We are also interested to explore whether or not micronutrients may have an impact on any of the mental health effects generated by the 2020 COVID-19 outbreak.

200 participants will be randomised to a placebo or treatment condition.

Participation is limited to people living in the Canterbury (Otautahi/Waitaha) region.

The treatment condition will involve taking 12 multi-nutrient tablets per day (4 pills, 3 times a day) for 10 weeks.

The trial will also include a 2 week initial baseline phase, where no treatment or placebo will be offered.

Participants will complete initial assessment questionnaires and weekly monitoring of their symptoms.

At the conclusion of the trial, all participants will be offered multi-nutrients for a further 10 weeks in an open trial phase.

The trial has been prospectively registered under the Australian and New Zealand Clinical Trials Registry. Trial Identification = ACTRN12617001647325. Universal Trial Number = U111111994026. Ethics approval was granted through the New Zealand Heath and Disability Ethics Committee 17/STH/131 on 14 November 2017 and the University of Canterbury Human Ethics Committee: HEC2017/108/LR, on 27 November 2017.

The results from the trial will be published when the trial is completed.

What is the intervention?

The multi-nutrient formula that will be used in the trial is Daily Essential Nutrients. The ingredients are as follows:

Ingredients: 1 capsule 12 capsules
Vitamin A (as retinyl palmitate) 480 IU 5,760 IU
Vitamin C (as ascorbic acid) 50 mg 600 mg
Vitamin D (as cholecalciferol) 250 IU 3,000 IU
Vitamin E (as d-alpha tocopheryl succinate) 30 IU 360 IU
Vitamin K (75% as phylloquinone; 25% as menaquinone-7) 10 mcg 120 mcg
Thiamin (as thiamin mononitrate) 4 mg  60 mg
Riboflavin 1.5 mg 18 mg
Niacin (as niacinamide) 7.5 mg 90 mg
Vitamin B6 (as pyridoxine hydrochloride) 5.8 mg 69.9 mg
Folate (as L-methylfolate calcium) 66.8 mcg 801 mcg
Vitamin B12 (as methylcobalamin) 75 mcg 900 mcg
Biotin 90 mcg 1080 mcg
Pantothenic acid (as d-calcium pantothenate) 2.5 mg 30 mg
Calcium (as chelate) 110 mg 1,320 mg
Iron (as chelate) 1.15 mg 13.8 mg
Phosphorus (as chelate) 70 mg 840 mg
Iodine (as chelate) 17 mcg 204 mcg
Magnesium (as chelate) 50 mg 600 mg
Zinc (as chelate) 4 mg 48 mg
Selenium (as chelate) 17 mcg 204 mcg
Copper (as chelate) 0.6 mg 7.2 mg
Manganese (as chelate) 0.8 mg 9.6 mg
Chromium (as chelate) 52 mcg 624 mcg
Molybdenum (as chelate) 12 mcg 144 mcg
Potassium (as chelate) 20 mg 240 mg
Proprietary blend ingredients:
Choline bitartrate
Alpha-lipoic acid
Shilajit
Inositol
Acetylcarnitine (as acetyl-L-carnitine hydrochloride)
Grape seed extract
Ginkgo biloba leaf extract
Methionine (as L-methionine hydrochloride)
Cysteine (as N-acetyl-L-cysteine)
Germanium sesquioxide (as chelate)
Boron (as chelate)
Vanadium (as chelate)
Lithium orotate (as chelate)
Nickel (as chelate)
Other ingredients:
Cellulose
Glycine
Citric acid
Magnesium stearate
Silicon dioxide

The placebo formula ingredients are as follows:

Ingredients: 1 capsule 12 capsules
Fiber Acacia Gum 300 mg 3,600 mg
Maltodextrin 395.90 mg 4,750.8 mg
Cocoa Powder 4 mg 48 mg
Riboflavin Powder 0.10 mg 1.2mg

Inclusion and Exclusion criteria

Not everyone will be able to participate in the NoMAD trial. Because this is a clinical trial, we have some criteria about who we can accept. This is for everyone’s safety. If you have any questions these criteria or your eligibility, please speak to your GP or contact the Principal Investigator (see contact form below)

Who we can accept (Inclusion):

1) People between 18 and 65 years,

2) You must have access to the internet, either at your home, work/mahi or easily accessible public wifi/internet (local libraries can be a great place to get wifi).

3) You must be able to swallow capsules. During the trial, you will be asked to take up to 12 capsules per day (with food and water). If you struggle to swallow capsules or pills, this may not be the trial for you.

4) You must be experiencing symptoms of anxiety and depression that are really impacting your life, making it difficult for you to do day-to-day tasks.

5) You must be living in the Canterbury (Otautahi/Waitaha) area.

Who we can’t accept (Exclusion):

If any of these points apply to you, it is unlikely you will be eligible to participate. Speak to your GP about other things you could do to assist with anxiety and/or depression.

1) If you experience metabolic conditions such as Wilson’s disease (copper), haemochromatosis (iron), phenylketonuira (phenylalanine) and trimethylaminuria (choline).

2) If you have been diagnosed with Neurological (brain) disorders e.g., intellectual disability, autism spectrum disorder, epilepsy, multiple sclerosis.

3) If your mental health issues are so severe you require hospitalisation or are feeling seriously suicidal. If this is the case, you need to speak with your GP about options for treatment.

4) If you have serious problems with substances such as alcohol or cannabis or struggle with psychotic symptoms (hearing voices or seeing things that other people can’t see or hear).

4) Some other serious medical conditions can be problematic. If you have a serious medical condition, please use the contact form below to check in with the Principal Investigator or speak to your GP about whether this trial is right for you.

4) If you might be allergic to any of the ingredients in the products used (see above).

5) If you are regularly taking any medications for psychological difficulties. This includes anti-depressants (e.g. Citalopram), anti-anxiety medication (e.g. Lorazepam) or sleeping medication (e.g. Zopiclone). You must have been off of these medications for a minimum of four weeks prior to the trial and we do not recommend you stop taking your medications to participate in the trial. If you are taking any of the previously mentioned medications, please speak to your GP about other options for your mental health.

6) There are some other medications that can have interactions with multi-nutrients (e.g. medication for thyroid conditions). We will speak with you about these medications and may decline participation in the trial if we think your medications might interact badly with the products we use. Please contact us for more information if you are concerned about potential interactions (contact form below).

Please also be aware that if you are regularly taking other nutritional supplementation (e.g. magnesium, Vitamin D) you may be asked to stop taking these for the duration of the trial.

7) Women who are pregnant or breastfeeding. If you are pregnant and interested in participating, please see the link below that will take you to the study very similar to NoMAD for pregnant women/wahine.

For more information on a current trial exploring multi-nutrients, depression and anxiety in pregnancy: www.bit.ly/pregnancy-study

To self-refer to the trial, please provide your details in the form below:

Please note: information in referral boxes is a guide to completion, not actual information.

For more information, please contact Meredith Blampied (Principal Investigator):

References:

Davison, K. M., & Kaplan, B. J. (2012a). Nutrient intakes are correlated with overall psychiatric functioning in adults with mood disorders. Canadian Journal of Psychiatry, 57(2), 85-92.

Davison, K. M., & Kaplan, B. J. (2012b). Food intake and blood cholesterol levels of community-based adults with mood disorders. BMC Psychiatry, 12. doi:10.1186/1471-244X-12-10

Gariballa, S., & Forster, S. (2007). Effects of dietary supplements on depressive symptoms in older patients: A randomised double-blind placebo-controlled trial. Clinical Nutrition, 26(5), 545-551. doi:http://ddoi.org/10.1016/j.clnu.2007.06.007

Lothian, J., Blampied, N.M., & Rucklidge, J.J. (2016). Effect of Micronutrients on Insomnia in Adults: A Multiple-Baseline Study. Clinical Psychological Science, 4(6), 1112-1124.

O’Neil, A., Quirk, S. E., Housden, S., Brennan, S. L., Williams, L. J., Pasco, J. A., . . . Jacka, F. N. (2014). Relationship between diet and mental health in children and adolescents: a systematic review. American journal of public health, 104(10), e31-e42.

Popper, C. W. (2014). Single-Micronutrient and Broad-Spectrum Micronutrient Approaches for Treating Mood Disorders in Youth and Adults. Child and Adolescent Psychiatric Clinics of North America, 23(3), 591-672. doi:10.1016/j.chc.2014.04.001

Robson, D., & Gray, R. (2007). Serious mental illness and physical health problems: a discussion paper. International journal of nursing studies, 44(3), 457-466.

Rucklidge, J. J., Blampied, N., Gorman, B., Gordon, H. A., & Sole, E. (2014). Psychological functioning 1 year after a brief intervention using micronutrients to treat stress and anxiety related to the 2011 Christchurch earthquakes: A naturalistic follow-up. Human Psychopharmacology, 29(3), 230-243. doi:10.1002/hup.2392

Ruckildge, J.J., Eggleston, M.J.F., Ealam, B., Beaglehole, B., & Mulder, R.T. (2019). An observational preliminary study on the safety of long-term consumption of micronutrients for the treatment of psychiatric symptoms. The Journal of Alternative and Complimentary Medicine, oo(00), 1-10. doi: 10.1089/acm.2018.0352

Rucklidge, J. J., Frampton, C. M., Gorman, B., & Boggis, A. (2014a). Vitamin-mineral treatment of attention-deficit hyperactivity disorder in adults: double-blind randomised placebo- controlled trial. The British Journal of Psychiatry, 204(4), 306

Schlebusch, L., Bosch, B. A., Polglase, G., Kleinschmidt, I., Pillay, B. J., & Cassimjee, M. H. (2000). A double-blind, placebo-controlled, double-centre study of the effects of an oral multivitamin- mineral combination on stress. S Afr Med J, 90(12), 1216-1223.

Simpson, J. S. A., Crawford, S. G., Goldstein, E. T., Field, C., Burgess, E., & Kaplan, B. J. (2011). Systematic review of safety and tolerability of a complex micronutrient formula used in mental health. BMC Psychiatry, 11. doi:10.1186/1471-244X-11-62

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