Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

This study has been completed.

Study NCT00067405. Last updated on April 21, 2008. Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

Official Title ^†

Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

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.

Detailed Description

As per Brief Summary

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Fibromyalgia

Intervention ^†

Drug: Intravenous micronutrient therapy

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

June 2004

Completion Date

July 2007

Eligibility 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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00067405

Organization ID

R21 AT000942-01A1

Secondary IDs ^††

Katz

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

David Katz, MD

Yale-Griffin Prevention Research Center

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

April 2008

First Received Date ^†

August 18, 2003

Last Updated Date

April 21, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.