Objective: Report safety, tolerability, serum micronutrient concentrations and their correlations with mood changes from an 8-week pilot feasibility study of a 36-ingredient multinutrient supplement, Truehope® EMPowerplus, for pediatric bipolar spectrum disorders (BPSD).
Method: Ten children aged 6-12 received Truehope® EMPowerplus escalating from 1 to 4 capsules t.i.d., with four children increased to the maximum suggested dose, 5 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.
Result: Seven children (70%) completed the study. Three (30%) terminated early due to tolerability and compliance issues. Adverse effects were mild and transient, and chiefly initial insomnia or GI upset. No differences occurred in BMI (p = 0.310) or waist-hip ratio (WHR; p = 0.674) pre- to post-supplementation. Four of the tested serum vitamin concentrations increased from pre- to post-supplementation: vitamin A- retinol; vitamin B6; vitamin E-ƒ¿-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 post- supplementation, suggesting blood nutrient level increases were due to Truehope EMPowerplus.
Conclusion: In this open prospective study, short-term use of Truehope® EMPowerplus in children with BPSD appeared safe and well-tolerated, 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 doc mentation of increased serum concentrations of specific micronutrients.