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Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Intravenous micronutrient therapy
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Intravenous micronutrient therapy, IVMT, alternative medicine, complementary medicine, vitamins, vitamin supplements

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale-Griffin Prevention Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 18, 2003
Last Updated
April 21, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00067405
Brief Title
Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia
Official Title
Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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
As per Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Intravenous micronutrient therapy, IVMT, alternative medicine, complementary medicine, vitamins, vitamin supplements

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intravenous micronutrient therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Katz, MD
Organizational Affiliation
Yale-Griffin Prevention Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-Griffin Prevention Research Center
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19250003
Citation
Ali A, Njike VY, Northrup V, Sabina AB, Williams AL, Liberti LS, Perlman AI, Adelson H, Katz DL. Intravenous micronutrient therapy (Myers' Cocktail) for fibromyalgia: a placebo-controlled pilot study. J Altern Complement Med. 2009 Mar;15(3):247-57. doi: 10.1089/acm.2008.0410.
Results Reference
derived

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Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

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