Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia | NCT00067405

Studies
Intravenous Micronutrient Therapy (IVMT) for Fibromyalgia

NCT00067405

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Status

Completed

Last Update Posted

Apr 22, 2008Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Fibromyalgia

Interventions

Intravenous micronutrient therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Katz

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2004

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Aug 18, 2003

First Submission Date that Met QC Criteria

Aug 19, 2003

First Posted Date

Aug 20, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2008

Last Update Posted Date

Apr 22, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Intravenous micronutrient therapy	Drug

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Katz, MD	Yale-Griffin Prevention Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale-Griffin Prevention Research Center		Derby	Connecticut	06418	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19250003	Derived	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.

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases