Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067405
• Other study ID #: R21AT000942-01A1
• Secondary ID: Katz
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 18, 2003
• Last updated: April 21, 2008
• Start date: June 2004
• Est. completion date: July 2007

Study information

• Verified date: April 2008
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

As per Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Intravenous micronutrient therapy

Locations

Country	Name	City	State
United States	Yale-Griffin Prevention Research Center	Derby	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,