Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00067405
First received: August 18, 2003
Last updated: April 21, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Fibromyalgia
Drug: Intravenous micronutrient therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

Resource links provided by NLM:


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

Estimated Enrollment: 40
Study Start Date: June 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Detailed Description:

As per Brief Summary

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067405

Locations
United States, Connecticut
Yale-Griffin Prevention Research Center
Derby, Connecticut, United States, 06418
Sponsors and Collaborators
Investigators
Principal Investigator: David Katz, MD Yale-Griffin Prevention Research Center
  More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00067405     History of Changes
Other Study ID Numbers: R21 AT000942-01A1, Katz
Study First Received: August 18, 2003
Last Updated: April 21, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Fibromyalgia
Intravenous micronutrient therapy
IVMT
alternative medicine
complementary medicine
vitamins
vitamin supplements

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014