Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

This study has been completed.

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

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 I Phase II

MedlinePlus related topics: Fibromyalgia

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:

Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

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

Estimated Enrollment:

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:

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

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

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

David Katz, MD

Yale-Griffin Prevention Research Center

More Information

Study ID Numbers:

R21 AT000942-01A1, Katz

First Received:

August 18, 2003

Last Updated:

April 21, 2008

ClinicalTrials.gov Identifier:

NCT00067405

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

Study placed in the following topic categories:

Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 07, 2009