Nutritional and Safety Outcomes from an Open-Label Micronutrient Intervention for Pediatric Bipolar Spectrum Disorders

Abstract

Objective: The purpose of this study was to report the safety, tolerability, and serum micronutrient concentrations and their correlations with mood changes from an 8 week pilot feasibility study of a 36 ingredient multinutrient supplement, EMPowerplus (EMP+), for pediatric bipolar spectrum disorders (BPSD). Methods: Ten children ages 6-12 received EMP + escalating from one to four capsules t.i.d., with four children increased to the maximum suggested dose, five capsules t.i.d. Outcome measures were micronutrient concentrations in serum and red blood cells, vital signs, body mass index (BMI), dietary intake (Food Frequency Questionnaire and 24 hour dietary recall interview), and mood and global functioning ratings. Results: Seven children (70%) completed the study. Three (30%) terminated early for tolerability and compliance issues. Adverse effects were mild and transient, and chiefly consisted of initial insomnia or gastrointestinal (GI) upset. No differences occurred in BMI ( p = 0.310) or waist-hip ratio (WHR; p = 0.674) pre-to postsupplementation. Four of the tested serum vitamin concentrations increased from pre-to postsupplementation: vitamin A-retinol, vitamin B6, vitamin E-a-tocopherol; and folate (all p < 0.05). The increase in serum 25-OH vitamin D approached significance ( p = 0.063). No differences were found in dietary intake pre-to postsupplementation, suggesting that blood nutrient level increases were caused by EMP + . Conclusions:In this open prospective study, short-term use of EMP + in children with BPSD appeared safe and welltolerated, with a side effect profile preferable to first-line psychotropic drugs for pediatric bipolar spectrum disorders. A double-blind, randomized clinical trial is feasible, appears safe, and is warranted by open-label clinical outcomes and plausible mechanisms of action, combined with documentation of increased serum concentrations of specific micronutrients.

Vitamin‐mineral treatment improves aggression and emotional regulation in children with ADHD: a fully blinded, randomized, placebo‐controlled trial

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

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Nutrition Provides the Essential Foundation for Optimizing Mental Health

“…There have been numerous clinical observations and open-label trials of broad-spectrum multinutrients (Frazier et al, 2013;Kaplan, Hilbert, et al, 2015;Kaplan et al, 2001;Popper, 2001), as well as case studies (Kaplan et al, 2002), and database analyses in adults (Gately & Kaplan, 2009) and children (Rucklidge et al, 2010) with bipolar disorder, all showing significant improvement in symptoms and the need for a reduced amount of medication to maintain symptom control for most of the participants.…”