NCT00067405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2003

Completed
10 months until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

3.1 years

First QC Date

August 18, 2003

Last Update Submit

April 21, 2008

Conditions

Fibromyalgia

Keywords

FibromyalgiaIntravenous micronutrient therapyIVMTalternative medicinecomplementary medicinevitaminsvitamin supplements

Interventions

Intravenous micronutrient therapyDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Related Publications (1)

  • 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.

    PMID: 19250003DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • David Katz, MD

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 18, 2003

First Posted

August 20, 2003

Study Start

June 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

US(1)