None listed
Conditions
Brief summary
A high level of anxiety or anxiety disorder during childhood is a risk factor for continued mental health problems in adolescence and adulthood as well as having a significant impact on children’s peer relations, schooling and family life. While treatments are available for this condition, these can often be costly and time-consuming or result in side effects. These factors may cause families to seek out alternative options. 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 anxiety and mood symptoms in children with elevated anxiety and stress levels. One micronutrient formula called EMPowerplus (EMP+; a micronutrient formula with 36 ingredients sold in NZ) has been receiving increasing attention internationally as a promising treatment for many psychiatric disorders, including anxiety and mood disorders and ADHD. Our research team has published results on open label trials and case studies showing that EMP+ has significant effects on mood, anxiety and stress in children and adults. This study plans to extend research investigating stress in adults to children in a pilot study using a multiple baseline design.
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. The dose will be 4 oral capsules twice a day. The design consists of three multiple baseline, 5 per group. Each group starts at a different time from baseline as determined by randomly assigning each person to one of three starting points from baseline (1, 2 or
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. The dose will be 4 oral capsules twice a day. The design consists of three multiple baseline, 5 per group. Each group starts at a different time from baseline as determined by randomly assigning each person to one of three starting points from baseline (1, 2 or 3 weeks). Each group takes the micronutrients for 8 weeks. Participants are followed 3 months post-trial
Sponsors
Department of Psychology, University of Canterbury
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
1. Participants are between 8-11 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 8 capsules/day). 3. Participants must be able to eat at least a snack two times per day, so that the capsules will not be ingested on an empty stomach. 4. Participants meet criteria for elevated anxiety as assessed by the SCARED. They would also require a CGAS score of at least 50.
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 participant known to be allergic to the ingredients of the intervention (including ginkgo biloba, germanium sesquioxide, or grape seed) will be excluded. 4. Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis). 5. 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. 6. Participants will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. 7. Any type of nutritional or herbal supplement, known to have a centrally-acting effect, will result in a participant's exclusion. However, participants 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. 7. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
Outcome results
None listed