title: 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-α-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 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 documentation of increased serum concentrations of specific micronutrients.
authors.affiliation: Department of Psychiatry, Department of Human Nutrition, The Ohio State University , Columbus, Ohio.
authors.forename: Elisabeth A
authors.initials: EA
authors.lastname: Frazier
authors.forename: Barbara
authors.initials: B
authors.lastname: Gracious
authors.forename: L Eugene
authors.initials: LE
authors.lastname: Arnold
authors.forename: Mark
authors.initials: M
authors.lastname: Failla
authors.forename: Chureeporn
authors.initials: C
authors.lastname: Chitchumroonchokchai
authors.forename: Diane
authors.initials: D
authors.lastname: Habash
authors.forename: Mary A
authors.initials: MA
authors.lastname: Fristad
mesh_terms: D001714:Bipolar Disorder / Q000188:drug therapy*; D002648:Child; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D018977:Micronutrients / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use*; D010865:Pilot Projects; D011446:Prospective Studies
chemical_list: D018977:Micronutrients