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Study of T3 for the Treatment of Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00903877
Recruitment Status : Completed
First Posted : May 19, 2009
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Study Description
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Brief Summary:
Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: T3 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial
Study Start Date : May 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo followed by T3
Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
 Drug: T3
Patients receive T3 in a dose of 25mcg and 50mcg


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Scale of Pain Intensity [ Time Frame: 12 weeks ]
    Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-50
  2. Meet american college of rheumatology criteria for fibromyalgia
  3. at baseline report an average pain of 4 or more on a brief Pain Inventory.
  4. can climb 2 flights of stairs without shortness of breath.

Exclusion Criteria:

  1. new medication change in the last 2 months
  2. any cardiac disease at all
  3. known thyroid disease before or after thyroid screening bloodwork
  4. unstable medical or psychiatric disease.
  5. Known inflammatory or rheumatic disease other than fibromyalgia
  6. substance abuse in the last year
  7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
  8. concomitant herbal medications
  9. multiple severe medication allergies
  10. the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
  11. diabetes
  12. smoking
  13. Known uncontrolled hypertension
  14. known uncontrolled hypercholesterolemia
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00903877


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Ian R Carroll Stanford University
More Information
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Responsible Party: Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00903877    
Other Study ID Numbers: SU-04272009-2419
16295
First Posted: May 19, 2009    Key Record Dates
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases