Study of T3 for the Treatment of Fibromyalgia
Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Fibromyalgia
Intervention: T3 (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Stanford University Official(s) and/or principal investigator(s): Ian R Carroll, Principal Investigator, Affiliation: Stanford University
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.
Clinical Details
Official title: T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Visual analogue scale of pain intensity
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information
Starting date: May 2009
Last updated: June 21, 2012
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