Human Subject Research with
Nutritional Supplements
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Unpublished; informed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Results are unpublished.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
Alternative Medicine:
[http://www.pas-meeting.org/Meetings/2001/Saturday.htm]
;
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.