An Observational Preliminary Study on the Safety of Long-Term Consumption of Micronutrients for the Treatment of Psychiatric Symptoms

Abstract

Objectives: There is an increasing body of literature documenting the efficacy of micronutrients (vitamins and minerals) interventions for the treatment of psychiatric problems in the short term; however, long-term safety is largely unexplored. The goal of this observational study was to investigate the safety of two commercially available broad-spectrum micronutrient formulas (EMPowerplus and Daily Essential Nutrients) given at doses above the Recommended Dietary Allowances for the long-term treatment of individuals with psychiatric symptoms. Design: Participants on long-term treatment with micronutrients (medication-free) for psychiatric problems (attention-deficit hyperactivity disorder [ADHD, n = 21], anxiety/depression [n = 13]) were identified from ongoing research studies and the community through purchasing records. Seventeen children and 17 adults had blood tests to assess their full blood count, coagulation profile, liver and kidney function, fasting glucose, iron studies, key nutrients, and prolactin. Questionnaires assessed psychological/psychiatric functioning. Seventeen of the participants had completed the same measures pretreatment. Results: The average length of consuming micronutrients was 2.66 years (standard deviation = 2.86). Excluding B 12 (which was elevated for almost all participants), 94.6% of all blood test results were within the test reference ranges. One participant was diagnosed with hemochromatosis based on iron studies. No other clinically relevant adverse changes in blood results were identified pre-and post-treatment. No clinically significant adverse effects were reported. Post-treatment psychometrics identified that 85% of the participants were in nonclinical ranges for measures of ADHD, depression, anxiety, and stress. Conclusions: We report preliminary evidence for the safety of long-term commercially available micronutrients, although questions remain. Overall, the substantial psychiatric benefits observed appear to outweigh the minimal observed risks in these participants. Screening for potential medical problems is recommended before initiating treatment. Long-term pharmacovigilance monitoring is required to ascertain any rare but significant adverse events.

Do Changes in Blood Nutrient Levels Mediate Treatment Response in Children and Adults With ADHD Consuming a Vitamin–Mineral Supplement?

“…Full efficacy and safety of EMP/DEN have been reported elsewhere (Rucklidge, Eggleston, Ealam, Beaglehole, & Mulder, 2019; Simpson et al, 2011); overall, EMP/DEN has a reassuring safety profile with no serious adverse events reported. Safety data including laboratory values and adverse events occurring during the child and adults RCTs have been previously reported (Rucklidge et al, 2018; Rucklidge, Frampton, et al, 2014).…”

Nutrition Provides the Essential Foundation for Optimizing Mental Health

“…Several of the studies have collected safety data (via blood tests, heart rate, blood pressure) before and after exposure to the nutrients, typically over two or three months, some over several years. In all of these studies, amounting to several hundred blood tests before and after multinutrient use, no evidence of clinically meaningful short-term or long-term harm has emerged (Adams et al, 2018;Rucklidge, Eggleston, Ealam, et al, 2019;Rucklidge et al, 2018;Simpson et al, 2011).…”

Multinutrients for the Treatment of Psychiatric Symptoms in Clinical Samples: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…Supplementation with a multinutrient formula may require a dose reduction to avoid symptoms due to pharmacodynamic interactions. The long-term safety of multinutrient use has been observationally studied (n = 35) for up to 12 years of use (average = 3.75 years (SD = 3.63), with a range of 0.83-12 years), as demonstrated by blood work and participant responses [83].…”