None listed
Conditions
Brief summary
Attention-Deficit/Hyperactivity Disorder (ADHD) is a chronic illness that affects 3-5% of the population. It is associated with many other conditions and is a risk factor for continued mental health problems. While many medications are widely used for this condition, the side effects and lack of long-term efficacy data cause many families to seek out alternative options. Micronutrients (vitamins and minerals) are receiving growing recognition as a promising treatment for many psychiatric disorders, including bipolar disorder, depression and ADHD. This study plans to investigate the impact of micronutrients on ADHD and mood symptoms in children using a pilot single case on-off-on-off design.
Interventions
ABAB design (on-off-on-off) using a vitamin and mineral formula (EMPowerplus) for the treatment of ADHD in children. Empowerplus contains 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, www.truehope.com. Participants first take 8 pills a day for 4 weeks; if there is no response, the dose is increased to 15 pills a day for another 4 weeks. After 8 weeks taking pills, participants are taken off for 4 weeks
ABAB design (on-off-on-off) using a vitamin and mineral formula (EMPowerplus) for the treatment of ADHD in children. Empowerplus contains 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, www.truehope.com. Participants first take 8 pills a day for 4 weeks; if there is no response, the dose is increased to 15 pills a day for another 4 weeks. After 8 weeks taking pills, participants are taken off for 4 weeks, put back on at the optimal dose for 8 weeks and then taken off again for 4 weeks.
Sponsors
Department of Psychology, University of Canterbury
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Participants are between 8-12 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 as assessed by the K-SADS (Kaufman, et al., 1997), the Conners Rating Scales (score greater than 70 on either parent or teacher form; (Conners, 1997).
Exclusion criteria
1. Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy). Purely peripheral neurological problems are not excluded (e.g., Raynaud’s, peripheral diabetic neuropathy). 2. Any serious medical condition for which major medical interventions are anticipated during the duration of the trial. 3. Any patient known to be allergic to the ingredients of the intervention (including ginkgo biloba, germanium sesquioxide, or grape seed) will be excluded. 4. Evidence of untreated or unstable thyroid disease (thyroid testing will occur at baseline). 5. Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis). 6. Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial. 7. Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. 8. Any type of nutritional or herbal supplement, known to have a centrally-acting effect, will result in a patient's exclusion. However, patients who have been taking supplements such as echinacea, chondroitin, or glucosamine may enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continue on these agents throughout the study. We will permit people to take as much as 1 g/day of EPA and DHA combined. 9. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
Outcome results
None listed