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Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

NCT ID: NCT00067405

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-07-31

Brief Summary

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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

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As per Brief Summary

Conditions

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Fibromyalgia

Keywords

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Fibromyalgia Intravenous micronutrient therapy IVMT alternative medicine complementary medicine vitamins vitamin supplements

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Intravenous micronutrient therapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Principal Investigators

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David Katz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale-Griffin Prevention Research Center

Locations

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Yale-Griffin Prevention Research Center

Derby, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 19250003 (View on PubMed)

Other Identifiers

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Katz

Identifier Type: -

Identifier Source: secondary_id

R21AT000942-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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