None listed
Conditions
Brief summary
It has been proposed that some vitamins and minerals (together known as micronutrients) might help people with mood instability to stabilize their mood. When a new idea such as this comes along, it must be studied first in a variety of people (referred to as case series), and then in a controlled trial. The case series that have been carried out on EMPowerplus suggest that it might help to stabilize mood and help with some symptoms of ADHD. Often when people participate in trials, such as an open-label trial, they get better simply because of the contact with a health professional, the care they receive and the belief that they will get better. An RCT will help determine with more confidence the effect these pills have on the symptoms being measured.
Interventions
Double blind randomized controlled trial (RCT) comparing a mineral and vitamin supplement (EMpowerplus) with a placebo followed with an open-label extension. 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.
Double blind randomized controlled trial (RCT) comparing a mineral and vitamin supplement (EMpowerplus) with a placebo followed with an open-label extension. 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. They then enter an open label trial for a further 8 weeks with the same dose of EMpowerplus.
Sponsors
Julia Rucklidge
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1.Participants are older than 16 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.
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