None listed
Conditions
Brief summary
Broad spectrum micronutrient formulations are combinations of vitamins and minerals that can be used for treatment purposes. There is emerging evidence for the use of these formulations to treat anxiety, depression and other mental disorders. The majority of studies evaluating broad spectrum micronutrients have done so as a primary treatment (not added to conventional psychiatric medications). These studies have produced promising results and have shown that broad spectrum micronutrient formulas are well tolerated and do not appear to cause toxicity (abnormal physical findings or blood tests). The safety and effectiveness of combination use of broad spectrum micronutrient formulations and medications has not been formally evaluated in studies. This is a significant gap. Product databases provide preliminary data on the experience of children and adults taking broad spectrum micronutrient formulations while on antidepressant and other medications. These databases suggest that broad spectrum micronutrient formulations can be combined satisfactorily psychiatric medication although it is recommended to introduce micronutrients slowly and review psychiatric medication regularly due to expert opinion suggesting that micronutrients may increase the levels of antidepressants. It is important to clarify if there are interactions between broad spectrum micronutrient formulations and psychiatric medication in order for clarity on whether they can be taken in combination. If they are safe in combination, there will be further questions about whether or not clinical outcomes are improved by combination treatment. In order to clarify whether or not broad spectrum micronutrients interact with standard medications, and as an initial step prior to clarifying whether or not treatment with combination broad spectrum micronutrients and psychiatric medication improves the outcome of psychiatric disorders, a study testing for common broad spectrum micronutrient-drug interactions is required. We therefore propose to study broad spectrum micronutrient-drug interactions through the use of standard drug-interaction methodology. We hypothesise that there will not be significant interactions between commonly prescribed medications and broad spectrum micronutrients. Our study involves measurement of serum drug concentrations in healthy volunteers following ingestion of a ‘cocktail’ containing 5 medicines, each metabolised by different enzyme pathways. This testing will be done twice, before and after two weeks of regular daily micronutrients. If the serum concentrations of any of the 5 probe drugs are significantly changed by taking micronutrients, this is consistent with a pharmacokinetic drug interaction. This is essential information to inform prescribers about the use of combinations of broad spectrum micronutrients and medication, and to inform risk assessments for any future clinical studies of broad spectrum micronutrient formulations.
Interventions
Healthy volunteers will take a drug 'cocktail' by mouth (100mg caffeine, 25mg losartan, 20mg omeprazole, 30mg dextromethorphan syrup diluted in 50ml of plain water, 2mg midazolam in 50ml water) on two occasions. The first time will be in the absence of broad spectrum micronutrients. The second time will be in the presence of steady state broad spectrum micronutrients (after 13 days consumption). Adherence will not be monitored.
For broad spectrum micronutrients to be at steady state, they wi
Healthy volunteers will take a drug 'cocktail' by mouth (100mg caffeine, 25mg losartan, 20mg omeprazole, 30mg dextromethorphan syrup diluted in 50ml of plain water, 2mg midazolam in 50ml water) on two occasions. The first time will be in the absence of broad spectrum micronutrients. The second time will be in the presence of steady state broad spectrum micronutrients (after 13 days consumption). Adherence will not be monitored. For broad spectrum micronutrients to be at steady state, they will be consumed for 13 days; initially at 1 tablet three times daily increasing by 3 tabs (in divided doses) every second day until 4 tabs three times daily is reached. Broad spectrum micronutrients will be supplied by Hardy Nutritionals in the form of Daily Essential Nutrients. Daily Essential Nutrients are a complex mix of vitamins and minerals. There are more than 30 constituent ingredients including vitamins A,C,D,E,K and minerals Calcium, Iron, Phosphorus, and Magnesium.
Sponsors
University of Otago
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers Normal vital signs ECG normal On no regular medication DASS (a measure of anxiety, depression, and stress) in normal range) Not pregnant
Exclusion criteria
• Taking any regular medication including prescribed, over-the-counter, complementary and alternative medicines and recreational substances during the week prior to and for the duration of the study. Paracetamol will be permitted except during the clinic visit days. • Current smoker. • Consumption of large amounts of cruciferous vegetables during the 2 weeks prior to and for duration of study (cruciferous vegetables are CYP1A2 inducers). • Consumption of grapefruit juice for 48h before and for the duration of the study. • Prior adverse reaction to any of the drugs used in the study.
Outcome results
None listed