None listed
Conditions
Brief summary
There is very little research into the impact of complementary alternative medicines (CAM) on psychiatric illness yet thousands of New Zealanders use CAM as part of their treatments for all types of ailments. This study aims to investigate one type of CAM called Empowerplus (a micronutrient formula with 36 ingredients). Overseas studies are promising in that Empowerplus has been found to be effective in the treatment of Bipolar Disorder in adults, established through open-series designs, with the suggestion it may improve overall mood stability. However, to date no study has investigated its effect on attention or self-regulation despite the fact that thousands of families seek alternative treatments for ADHD. This study aims to do a pilot trial of MCN-36 with 25 ADHD adults with mood instability to investigate feasibility issues and initial impact of Empowerplus on attention and mood to determine if a larger scale trial should be launched.
Interventions
The intervention consists of a micronutrient formula called Empowerplus containing 36 ingredients: 14 vitamins, 16 minerals, 3 amino acids and 3 antioxidants. A list of the ingredients can be found on the company’s website, Truehope.com. Patients swallow 15 capsules a day divided into three doses of 5 pills each dose for a total of 8 weeks.
Sponsors
Julia Rucklidge
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Participants are older than 18 years of age. 2.Each participant must have a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of as many as 15 capsules/day). 3.Participants must be able to eat at least a snack three times per day, so that the capsules will not be ingested on an empty stomach. 4.Participants meet criteria for ADHD and show signs of some mood instability.
Exclusion criteria
1) neurological disorder involving brain or other central function (e.g., epilepsy, multiple sclerosis (MS), narcolepsy), 2) any serious medical condition for which major medical interventions was anticipated during the trial, 3) any patient known to be allergic to the ingredients of the intervention, 4) pregnancy or breastfeeding (pregnancy testing occurred at baseline and monthly thereafter), 5) evidence of untreated or unstable thyroid disease (thyroid testing will occur at baseline), 6) any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 7) evidence of substance dependence within the previous month, 8) any other medication with primarily central nervous system activity, including mood stabilizers (participants must have been off of these medications for a minimum of 4 weeks prior to the trial), 9) patients were excluded temporarily if they had taken an oral antibiotic in the previous 6 weeks (if an antibiotic was started during the course of the trial, that patient was withdrawn from the study), 10) any type of nutritional or herbal supplement, known to have a centrally-acting effect (patients who had been taking supplements such as echinacea, chondroitin, or glucosamine could enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continued on these agents throughout the study), and 11) any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
Outcome results
None listed