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History of Changes for Study: NCT00067405
Intravenous micronutrient therapy (IVMT) for Fibromyalgia
Latest version (submitted April 21, 2008) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 July 11, 2005 Contacts/Locations and Study Status
3 July 15, 2005 Study Status and Study Identification
4 March 16, 2006 Recruitment Status, Study Status, Contacts/Locations, Study Description and Study Identification
5 March 20, 2007 Study Status and Oversight
6 April 21, 2008 Recruitment Status, Study Status and Oversight
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Study NCT00067405
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: R21AT000942-01A1
Brief Title: Intravenous micronutrient therapy (IVMT) for Fibromyalgia
Official Title:
Secondary IDs: Katz
Open or close this module Study Status
Record Verification: July 2005
Overall Status: Recruiting
Study Start: June 2004
Primary Completion:
Study Completion: September 2005
First Submitted: August 18, 2003
First Submitted that
Met QC Criteria:
August 19, 2003
First Posted: August 20, 2003 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Center for Complementary and Integrative Health (NCCIH)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Intravenous micronutrient therapy
IVMT
alternative medicine
complementary medicine
vitamins
vitamin supplements
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms:
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 40
Open or close this module Arms and Interventions
Intervention Details:
Drug: Intravenous micronutrient therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Katie Campochiaro
Telephone: 203-732-1370
Email: katie.campochiaro@yalegriffinprc.org
Locations: United States, Connecticut
Yale-Griffin Prevention Research Center
[Recruiting]
Derby, Connecticut, United States, 06418
Contact:Contact: Alyse B. Sabina, MPH 203-732-1368 alyse.sabina@yalegriffinprc.org
Contact:Principal Investigator: David L. Katz, MD, MPH
Contact:Principal Investigator: Adam Perlman, MD, MPH
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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