International Micronutrient Malnutrition Prevention & Control Program |
IMMPaCt |
Clinical Trial: Intravenous micronutrient therapy (IVMT) for Fibromyalgia
This study is currently recruiting patients.
|
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 | Treatment or Intervention | Phase |
|---|---|---|
| Fibromyalgia | Drug: Intravenous micronutrient therapy | Phase I Phase II |
MedlinePlus related topics: Fibromyalgia
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 40
Study start: June 2004; Expected completion: September 2005
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
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.
Location and Contact Information
Connecticut
Yale-Griffin Prevention Research Center, Derby, Connecticut, 06418, United States; Recruiting
David L. Katz, MD, MPH, Principal Investigator
Adam Perlman, MD, MPH, Principal Investigator
More Information
Record last reviewed: September 2004
Last Updated: October 13, 2004
Record first received: August 18, 2003
ClinicalTrials.gov Identifier: NCT00067405
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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