From: Subject: Clinical Trial: Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia Date: Sun, 12 Nov 2006 10:11:40 -0800 MIME-Version: 1.0 Content-Type: multipart/related; type="text/html"; boundary="----=_NextPart_000_004F_01C70642.F277E3A0" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2900.2962 This is a multi-part message in MIME format. ------=_NextPart_000_004F_01C70642.F277E3A0 Content-Type: text/html; charset="iso-8859-1" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.clinicaltrials.gov/ct/show/NCT00067405 Clinical Trial: Intravenous Micronutrient Therapy = (IVMT) for Fibromyalgia
3DClinicalTrials.gov=20 3D"Linking
Home Search<= /TD> Listings Resources Help What's = New About 3D""=20

Intravenous Micronutrient Therapy (IVMT) for=20 Fibromyalgia

This study is no longer = recruiting=20 patients.

=
NCT00067405
Sponsored by: National= =20 Center for Complementary and Alternative Medicine = (NCCAM)
Information provided by: National Center for Complementary and=20 Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:

3D""=20 Purpose

The purpose of this = study is to=20 determine if intravenous micronutrient therapy (IVMT) is effective in = the=20 treatment of fibromyalgia, as assessed by validated functional and pain=20 measures.
Condition Intervention Phase
Fibromyalgia
 Drug: Intravenous = micronutrient=20 therapy
Phase = I
Phase=20 II

MedlinePlus related=20 topics:  Fibromyalgia

Study Type: Interventional
Study=20 Design: Treatment, Randomized, Double-Blind, Placebo Control,=20 Parallel Assignment, Efficacy Study

Official Title: Intravenous Micronutrient = Therapy (IVMT)=20 for Fibromyalgia

Further study details as provided by National = Center for=20 Complementary and Alternative Medicine (NCCAM):

Expected Total Enrollment:  40

Study start: June 2004;  Study = completion: July=20 2006

As per Brief = Summary

3D""=20 Eligibility

Ages Eligible for = Study:  18=20 Years   -   75 Years,  Genders Eligible for Study:  = Both=20
Criteria

Inclusion criteria:

  • Meet the American College of = Rheumatology criteria=20 for Fibromyalgia diagnosis;=20
  • On no medication for Fibromyalgia other than acetaminophen, or = willing to=20 stop all such medication for the duration of the study

    • Willing to stop all FMS medication = for the=20 duration of the study or be on a stable dose of such medication for = at least=20 3 months

Exclusion criteria:

  • Other concurrent medical conditions such as rheumatologic disease, = chronic=20 infection, untreated endocrine disorders, unstable seizures, = psychiatric=20 disorders, acute peptic ulcer disease, congestive heart failure, = chronic liver=20 disorders and/or bleeding problems

    • Allergy to thiamin
  • Unwilling to stop vitamin supplementation for the duration of the = study

    • PLEASE NOTE: Travel to and = accomodations at=20 the study site can NOT be compensated. Anyone wishing to travel from = outside=20 of the study site's geographic area must do so at their own risk and = expense.

3D""=20 Location Information


Connecticut
   &nb= sp;  Yale-Griffin=20 Prevention Research Center, Derby,  Connecticut,  = 06418, =20 United States=20

Study chairs or principal investigators

David Katz, MD,  Principal = Investigator, =20 Yale-Griffin Prevention Research Center   

3D""=20 More Information

Study ID Numbers:  R21 AT000942-01A1; = Katz
Last=20 Updated:  March 16, 2006
Record first received:  August 18, = 2003
ClinicalTrials.gov Identifier:  NCT00067405
He= alth=20 Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-11-09 =
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