None listed
Conditions
Brief summary
Attention Deficit/Hyperactivity Disorder (ADHD) is a chronic, debilitating psychiatric illness which begins in childhood, affecting 3-7% of the population worldwide. It is associated with many other psychiatric conditions and serves as a risk factor for offending behaviour and continued mental health problems into adulthood. While many treatments are widely used for ADHD, the side effects and lack of long-term efficacy data cause many families to seek out alternatives. Despite the growing popularity of complementary alternative medicines (CAM), there is very little research into the impact of CAM on psychiatric illness. This study aims to investigate the impact of micronutrients on children with ADHD. One micronutrient formula called Daily Essential Nutrients (DEN), a revision of EMPowerplus(EMP+) which is sold in NZ, has received international attention as a treatment for several psychiatric disorders including bipolar disorder, depression and ADHD. Our research team has published results using a variety of designs including open label, case studies and RCTs, showing that EMP+ has significant positive effects on mood, anxiety, hyperactivity, impulsivity and emotional lability. Given the encouraging results to date, this study seeks to conduct a randomized controlled trial of EMP+ using this revised formula, DEN, for children 7-12 years of age.
Interventions
Double blind randomized controlled trial (RCT) comparing a mineral and vitamin supplement (Daily Essential Nutrients) with a placebo followed with an open-label extension. The intervention consists of a micronutrient formula (Daily Essential Nutrients) containing 41 ingredients: The doses of each ingredient of one capsule are:
Vitamin A (as retinyl palmitate) 384 IU
Vitamin C (as ascorbic acid) 40 mg
Vitamin D (as cholecalciferol) 200 IU
Vitamin E (as d-alpha tocopheryl succinate) 24 IU
Vitamin
Double blind randomized controlled trial (RCT) comparing a mineral and vitamin supplement (Daily Essential Nutrients) with a placebo followed with an open-label extension. The intervention consists of a micronutrient formula (Daily Essential Nutrients) containing 41 ingredients: The doses of each ingredient of one capsule are: Vitamin A (as retinyl palmitate) 384 IU Vitamin C (as ascorbic acid) 40 mg Vitamin D (as cholecalciferol) 200 IU Vitamin E (as d-alpha tocopheryl succinate) 24 IU Vitamin K (as phylloquinone) 6 mcg Vitamin K (as menaquinone-7) 2 mcg Thiamin (as thiamin mononitrate) 4 mg Riboflavin 1.2 mg Niacin (as niacinamide) 6 mg Vitamin B6 (as pyridoxine hydrochloride) 4.6667 mg Folate (as folic acid) 50 mcg Folate (as L-methylfolate calcium) 50 mcg Vitamin B12 (as methylcobalamin) 60 mcg Biotin 72 mcg Pantothenic acid (as d-calcium pantothenate) 2 mg Calcium (as chelate) 88 mg Iron (as chelate) 0.916 mg Phosphorus (as chelate) 56 mg Iodine (as chelate) 13.6 mcg Magnesium (as chelate) 40 mg Zinc (as chelate) 3.2 mg Selenium (as chelate) 13.6 mcg Copper (as chelate) 0.48 mg Manganese (as chelate) 0.64 mg Chromium (as chelate) 41.6 mcg Molybdenum (as chelate) 9.6 mcg Potassium (as chelate) 16 mg Proprietary blend: Choline bitartrate, Alpha-lipoic acid, 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, Vanadium, Lithium orotate, Nickel. Other ingredients: Cellulose 49.122 mg Glycine 45 mg Citric acid 26.814 mg Magnesium stearate 24 mg Silicon dioxide 20 mg Participants swallow up to a target dose of 12 capsules a day divided into three doses of 4 pills each dose for a total of 10 weeks. Participants will begin by taking one capsule, 3 times each day, increasing the dose by three capsules every two days up to a target dose of 12 capsules per day: 4 taken at 3 different intervals (or the equivalent in powder form). Some participants may need to increase the dose more slowly. They then enter an open label trial for a further 10 weeks with the same dose of Daily Essential Nutrients (DEN). Compliance will be monitored with diaries and pill counts. All participants will then be followed up naturalistically 6 months and 1 year post trial.
Sponsors
University of Canterbury
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
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1) between 7 and 12 years, 2) considered reliable and compliant with the protocol (including the ingestion of as many as 12 capsules/day with food), and 3) meet criteria for ADHD as assessed by the K-SADS, and the Conners Rating Scales (T score greater than 65 on both parent and teacher form for any of the ADHD DSM-IV subscales). A subset (n=20) of children (males with Combined ADHD) will be asked to participate in an 1H-MRS pilot study in order to begin documenting the impact that nutrition has on the brains of ADHD children. Those participants must be compatible with the imaging scanner (i.e. no braces, no history of claustrophobia).
Exclusion criteria
1) Neurological disorder involving brain or other central function (e.g., intellectual disability as assessed by the Wechsler Intelligence Scale for Children, autism spectrum disorder, epilepsy, MS, narcolepsy) or other major psychiatric condition requiring hospitalization (e.g. significant mood disorder or psychosis), 2) Any serious medical condition, 3) Any patient known to be allergic to the ingredients of the intervention, 4) Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 5) Any other medication with primarily central nervous system activity, including stimulants. Participants must have been off of these medications for a minimum of four weeks prior to the trial.
Outcome results
None listed