The purpose of this trial is to determine whether a 36-ingredient micronutrient supplement (primarily vitamins and minerals) and fish oil (omega-3 fatty acid) supplement improves nutritional status and allows lower doses of conventional medications to be effective for bipolar disorder with fewer side effects, when studied under randomized and fully blinded conditions and compared to a placebo.
A follow-up open label phase will allow all participants, including those previously taking the placebo, to try the active micronutrient treatment for an additional twelve months.
Once the study participants complete the first twelve months of the randomized study they will transition onto the open label phase of the study. This is less intensive but will still involve quarterly check in, data collected and the micronutrient supplement + fish oil dispensed to participants by the researchers.
The investigators' hypothesis is the micronutrients and fish oil improves nutritional status and as we do not know the nutritional baseline of participants at the start the study, the longer we can follow the participants the better we will be able to understand the impact of taking this dose of vitamins over time. To achieve this we will need an additional $25,000 so the participants can check in quarterly, the data collected and the analysis completed.
"Evidence is steadily growing for the relationship between dietary quality and mental health, and for the select use of nutrient-based supplements to address nutritional deficiencies," explains Lewis Mehl-Madrona, MD, the study's principal investigator.
Some of the earliest research studies on nutrients relevant to mental illness observed irritability and mood problems in people known to be deficient in the B vitamins, while recent work on folic acid (vitamin B9) suggests that low levels may be associated with depressive symptoms and poor response to antidepressant medication. There are roughly 90 years of scientific literature demonstrating the relevance of dietary nutrients for mental health, forming the rationale for including the use of micronutrients. These are compelling reasons to explore the role of nutrition in the treatment of psychiatric disorders.