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Feasibility of a Nutritional Supplement As Treatment for Childhood Mood Dysregulation

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Feasibility of a Nutritional Supplement As Treatment for Childhood Mood Dysregulation Feasibility of a Nutritional Supplement as Treatment for Childhood Mood Dysregulation Thesis Presented in Partial Fulfillment of the Requirements for the Degree Doctor of Philosophy in the Graduate School of The Ohio State University By Elisabeth Anne Frazier, B.S. Graduate Program in Psychology The Ohio State University 2009 Thesis Committee: Mary Fristad, Ph.D., ABPP, Advisor Steven Beck, Ph.D., ABPP Michael Vasey, Ph.D. Copyright by Elisabeth Anne Frazier 2009 Abstract Current treatments for childhood mood dysregulation rely on psychotropic medications that are associated with significant adverse events (Kowatch et al., 2005). Human nutrition research suggests nutrients play an important role in physical and mental health and may be useful in treating mood dysregulation without the side effects of contemporary pharmaceuticals (Kaplan, Crawford, Field, & Simpson 2007). The current open-label study explored the feasibility of testing possible therapeutic effects of a multinutrient supplement, EMPowerplus (EMP+), as treatment for childhood mood dysregulation. Ten children, age 6-12 with mood dysregulation were recruited. All received EMP+ treatment. Mood symptoms were assessed seven times over an eight week trial. Blood draws were taken at baseline and final visits for nutrient analyses. Hypotheses included: 1) The sample can be recruited in 5 months; 2) Children aged 6-12 can swallow the supplement with >80% compliance; 3) Micronutrient levels of iron, copper, magnesium and zinc and vitamins B1, B6, B12, E and folate will increase after eight weeks of supplementation; 4) Depression scores, measured by the KDRS, will show a decreasing trend over the course of supplement treatment; and 5) Mania scores, measured by the KMRS, will show a decreasing trend over the course of supplement treatment. ii Results showed recruitment was completed in 6.5 months. Three participants terminated due to palatability and compliance issues. The mean sample compliance rate was approximately 91%. Of the seven study completers, all maintained at least 93% compliance and two maintained 100% compliance. Twelve, one-tailed Fisher Randomization Tests were computed, showing significant increases in blood levels of vitamins A, B6, D, E (alpha tocopherol) and folate from pre- to post-supplementation for the seven study completers (p<0.05). Two, one-tailed Fisher Randomization Tests showed significant decreasing trends in depression and mania scores for the seven study completers from baseline to the final visit, suggesting improvement and possible treatment response (p<0.05). Overall, results of this feasibility trial suggest recruitment for future studies is possible and may improve with summer recruitment. Also, children who meet swallowing inclusion criteria will likely have high medication compliance, but those who struggle swallowing capsules may not benefit from this intervention. This trial also shows children tolerate fasting and blood draw procedures well. Lastly, although open-label, significant decreasing trends in depression and mania scores throughout supplementation suggest future randomized, placebo-controlled trials of EMP+ are warranted. Suggestions for future research and limitations of the current study are discussed. iii Acknowledgments Thank you to the many mentors, faculty members, family and friends who have helped me complete this thesis. I am forever grateful for your continued support and encouragement. I would like to thank each of my committee members for helping me throughout this process. First, my sincere gratitude to my advisor, Dr. Mary Fristad, for introducing me to this exciting project and guiding me through each step along the way to its completion. She created the perfect balance of independence and advice over the course of multiple editing and feedback sessions as my thesis evolved. I cannot imagine having a better mentor. To Dr. Steven Beck, thank you for your excitement and support of this project. You have provided encouragement in the face of skepticism. Also, thank you to Dr. Michael Vasey for challenging me to think critically and helping to make me a better scientist. Thank you to all of the staff and faculty at The Ohio State University that helped make this study possible. Thank you to Dr. L. Eugene Arnold for sharing iv your knowledge of childhood nutrition and mental health as well as for taking the time to edit and guide my research. I am forever indebted to Dr. Mark Failla, Julie, and the rest of the human nutrition research team for teaching me the intricacies of human nutrition and guiding me in the interpretation of blood assays. I have learned more from you than I ever expected. A special thanks to the nurses, dieticians, and staff of the research clinic at The Ohio State University Center for Clinical and Translational Research. This project would not have been possible without your excellent care during blood draw and dietary monitoring visits. Also, thank you to Dr. Thomas Nygren and Dr. Joseph Verducci for your consultation regarding the statistical analyses for this thesis. Last but certainly not least, many thanks to my family and friends for their support throughout this crazy ride. Thank you all for pretending to understand and be interested in what I was talking about when I tried to explain my research. Also, thank you for your understanding during times when it seemed like I disappeared off the face of the Earth. A special thanks to Rob for calming me down in times of crisis and tracking down my work when I thought my computer had eaten it all. Finally, to Ryan and my parents, thank you for your encouragement and interest in this project. I love you all and truly appreciate your love and support. v Vita June 2002 . Chagrin Falls High School Chagrin Falls, Ohio May 2006. Bachelor of Science, Psychology Denison University 2006 to present . .Graduate Research Associate The Ohio State University Publications Fristad, M.A. & Frazier, E.A. (2008). Special treatment issues. In R. Findling, M. Fristad, & R. Kowatch (Eds.), Clinical Manual for the Management of Bipolar Disorder in Children and Adolescents (pp. 273-290). Arlington, VA: American Psychiatric Publishing, Inc. Fields of Study Major Field: Psychology Specialty: Clinical Child vi Table of Contents Abstract . .ii Acknowledgments . iv Vita . .vi List of Tables . ix List of Figures . .x Chapter 1: Introduction . .01 Chapter 2: Method . .23 Chapter 3: Results . .45 Chapter 4: Discussion . 57 References . .72 Appendix A: EMPowerplus (EMP+) 36-ingredient List . 80 Appendix B: Pill Swallowing Desensitization Protocol . .82 Appendix C: Demographic Form . 83 Appendix D: Medical History . .85 Appendix E: Physical Exam . 86 Appendix F: Side Effects Form . .87 vii Appendix G: Investigator’s Brochure . .88 Appendix H: Medication Accountability Form . 136 Appendix I: 24 Hour Recall/Typical Diet Form . 137 Appendix J: Individual Nutrient Blood Levels Pre- and Post- Supplementation. 138 Appendix K: Individual Mood Ratings Over Time . 145 viii List of Tables Table 1. Time course for data collection for EMP+ open-label pilot . .21 Table 2. Participant medication compliance over time . .46 Table 3. Mean nutrient blood levels pre- and post-EMP+ supplementation with normal range comparisons. .47 ix List of Figures Figure 1. Mean nutrient levels pre- and post- supplementation for vitamin B6, copper, vitamin D, ferritin, and magnesium. 48 Figure 2. Mean nutrient levels pre- and post- supplementation for vitamin A, carotenoids, vitamin E (alpha-tocopherol [a-TC] and gamma-tocopherol [g-TC]), folate, transferrin receptor (TfR), and zinc . 49 Figure 3. Depression ratings (KDRS) for all participants over time. 51 Figure 4. Mean depression ratings (KDRS) for study completers over time . 52 Figure 5. Mean intent to treat depression ratings (KDRS) over time . .53 Figure 6. Mania ratings (KMRS) for all participants over time . 54 Figure 7. Mean mania ratings (KMRS) for study completers over time. 55 Figure 8. Mean intent to treat mania ratings (KMRS) over time . 56 Figure 9. Participant 1 nutrient levels pre- and post- supplementation for vitamin B6, copper, vitamin D, ferritin, and magnesium . 138 Figure 10. Participant 1 nutrient levels pre- and post- supplementation for vitamin A, carotenoids, vitamin E (alpha-tocopherol [a-TC] and gamma- tocopherol [g-TC]), folate, transferrin receptor (TfR), and zinc . 138 Figure 11. Participant 3 nutrient levels pre- and post- supplementation for vitamin B6, copper, vitamin D, ferritin, and magnesium . 139 Figure 12. Participant 3 nutrient levels pre- and post- supplementation for vitamin A, carotenoids, vitamin E (alpha-tocopherol [a-TC] and gamma- tocopherol [g-TC]), folate, transferrin receptor (TfR), and zinc . 139 x Figure 13. Participant 5 nutrient levels pre- and post- supplementation for vitamin B6, copper, vitamin D, ferritin, and magnesium . 140 Figure 14. Participant 5 nutrient levels pre- and post- supplementation for vitamin A, carotenoids, vitamin E (alpha-tocopherol [a-TC] and gamma- tocopherol [g-TC]), folate, transferrin receptor (TfR), and zinc . 140 Figure 15. Participant 6 nutrient levels pre- and post- supplementation for vitamin B6, copper, vitamin D, ferritin, and magnesium . 141 Figure 16. Participant 6 nutrient levels pre- and post- supplementation for vitamin A, carotenoids, vitamin E (alpha-tocopherol [a-TC] and gamma- tocopherol [g-TC]), folate, transferrin receptor (TfR), and zinc . 141 Figure 17. Participant 7 nutrient levels pre- and post- supplementation for vitamin B6, copper, vitamin D,
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