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Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00067405
Recruitment Status : Completed
First Posted : August 20, 2003
Last Update Posted : April 22, 2008
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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Brief Summary:
The purpose of this study is to determine if intravenous micronutrient therapy (IVMT) is effective in the treatment of fibromyalgia, as assessed by validated functional and pain measures.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Intravenous micronutrient therapy Phase 1 Phase 2

Detailed Description:
As per Brief Summary
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia
Study Start Date : June 2004
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Meet the American College of Rheumatology criteria for Fibromyalgia diagnosis;

  • On no medication for Fibromyalgia other than acetaminophen, or willing to stop all such medication for the duration of the study

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

Exclusion criteria:

  • Other concurrent medical conditions such as rheumatologic disease, chronic infection, untreated endocrine disorders, unstable seizures, psychiatric disorders, acute peptic ulcer disease, congestive heart failure, chronic liver 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 the study site can NOT be compensated. Anyone wishing to travel from outside of the study site's geographic area must do so at their own risk and expense.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067405


Locations
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United States, Connecticut
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: David Katz, MD Yale-Griffin Prevention Research Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00067405    
Other Study ID Numbers: R21AT000942-01A1 ( U.S. NIH Grant/Contract )
Katz
First Posted: August 20, 2003    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Fibromyalgia
Intravenous micronutrient therapy
IVMT
alternative medicine
 complementary medicine
vitamins
vitamin supplements
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
 Nervous System Diseases
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs