Human Subject Research with
Conducted by B. Kaplan et al. with
Synergy Group of Canada “Nutrient Protocol”
and/or E M Power+
** Studies marked with ** indicate University of Calgary Conjoint Health Research Ethics Board approval prior to the incorporation of Evince International LLC, the manufacturer of record, on 19 December 1999, or the first production of E M Power+ in April 2000. Magic, eh?
**1. “Potential clinical benefit of nutritional supplements
in the management of fibromyalgia” L. Martin, B. Kaplan, The Journal of Musculoskeletal Pain 7 (4): 127-128, 1999. Case study, N=1, 13 month duration from November 1997 to December 1998. Investigational products described on p. 128 are consistent with those described in study number 2 below: Melaleuca Inc., Body Systems Technologies, T.J. Clark Inc.
**2. “A double blind case controlled study of the effects of a vitamin and mineral supplement as an adjunctive therapy for Attention Deficit Hyperactivity Disorder”; B. Kaplan. Approved 3 April 1997; concluded June 1998. Grant ID: 9621. Manufacturer of investigational products: Melaleuca Inc., Body Systems Technologies, T.J. Clark Inc. 12 pediatric subjects enrolled, 5 finished the trial.
Unpublished; informed consent documents requested under FOIA refused by the University of Calgary. In response to a question about funding for this study, they stated that this study had no funding.
3. Case study/open trial: N=1, “single-blind trial in a child with pervasive developmental disorder [PDD] and explosive rage.” B. Kaplan, correspondence of 23 May 2001 to Health Canada; 000228, ATIP A-2001-0845/ms. Investigational product unknown.
4. Pediatric trial, N=3, with crossover design on children with “irritable moods”, described in poster abstract: "Improved mood stability in nine children with a broad-based nutritional supplement”[poster 367] at the VIIth European Congress of Psychology in London 2001. Investigational product unknown.
5. Open trial: “Open trials of nutrient supplements”, B. Kaplan. Approval date unknown. Grant ID: 10326. 24 subjects enrolled, 22 finished the trial. Status: closed. Results are unpublished. [Possibly the study mentioned by co-investigator Dr. Chris Gorman in the Jan/Feb 2001 issue of the Newsletter of the Mood Disorders Association of British Columbia: “The original trial was an open design in which patients with various types of mental illness were maintained on their regular medications and each patient had the nutraceutical added. The results were equivocal, but the best outcome was with bipolar patients.” [http://www.truehope.com/press%20releases/mda_newsletter.htm]]
Investigational product unknown.
**6. Open pediatric trial: “Open trials of nutritional supplements for the treatment of children with anxiety/mood problems” , CHREB approval date 26 May 1999 [FOIA]. 11 children enrolled, 9 finished the trial. Study not listed under approved protocols or closed protocols. Investigational product: E M Power+. Results reported: Ferre R.C., Kaplan B.J. & Simpson J.S.A. Mood Stabilization with a Nutrient Supplement: A Case Series. American Academy of Child & Adolescent Psychiatry, Scientific Proceedings, 2000; Kaplan. B. at the annual meeting of the Pediatric Academic Society Baltimore MD, 2001 [presentation to Special Interest Group on Complementary and
the annual meeting of the Society of Biological Psychiatry, "Effective mood stabilization with a broad-based nutritional supplement: 21 adults and children" [poster 388] New Orleans LA, 2001, as "Improved mood stability in nine children with a broad-based nutritional supplement”[poster 367] at the VIIth European Congress of Psychology in London 2001.
**7. Randomized clinical trial with placebo: “A randomized controlled trial of a nutrient supplement in the treatment of fibromyalgia” L. Martin & B. Kaplan. Approved 16 June 1999. Grant ID: 10583. Funding from the Alberta Heritage Foundation for Medical Research, 1998 competition, approved March 1999: http://www.ahfmr.ab.ca/grants/HRF/1999funding/99projects.shtml, # 14; see also: http://www.ahfmr.ab.ca/publications/newsletter/May2000/Spring00/fibro.feat.htm. Investigational product: E M Power+[FOIA]. Current status unknown.
**8. Open adult trial: “Open trials of a nutraceutical treatment for mental disorders in adults”, CHREB approval 6 May 1999, B. Kaplan. Grant ID: 10561. 14 Adults enrolled, 11 completed the trial. Investigational product: E M Power+. Funding: Alberta Science and Research Authority [Project number: 99-03A], Alberta Children's Hospital Foundation, and Evince International LLC, which provided investigational drug E M Power+ free of charge. Results reported: "Successful treatment of bipolar disorder with a nutritional supplement: Ten cases” [poster] at the annual meeting of the Canadian Psychiatric Association, Vancouver BC, 2000; "Effective mood stabilization with a broad-based nutritional supplement: 21 adults and children" [poster 388] at the annual meeting of the Society of Biological Psychiatry, New Orleans LA, 2001. Published as "Effective mood stabilization with a chelated mineral supplement: An open-label trial in bipolar disorder" B. Kaplan et al. The Journal of Clinical Psychiatry 62 (12) 2001; 936-944. Current status: unknown.
**9. Randomized clinical trial, double blind with placebo: “Nutraceutical treatment of mental disorders: an RCT with Bipolar Disorder”, B. Kaplan. CHREB approval 24 August 1999. Grant ID: 10671. Target enrollment of 88 subjects. Investigational product: E M Power+. Funding: Alberta Science and Research Authority [Project number: 99-03A]. Current status: halted in late 2001 by Health Canada.
Studies for which funding has been awarded:
a) Clinical trial: head-to-head comparison of E M Power+ and conventional pharmaceutical treatment in adolescents newly diagnosed with mood disorders. Funding: Medical Services Foundation of Alberta, awarded June 2001. Status: on hold, pending government approval.
b) Clinical trial: mood instability in pediatric and adolescent subjects with autism, PDD, and ASD. Funding: Medical Services Foundation of Alberta, awarded June 2001. Status: on hold, pending government approval.
c) Clinical trial: teens, adolescents, and adults with mood disorders unspecified. Funding: Medical Services Foundation of Alberta, awarded June 2001. Status: on hold, pending government approval.