Study of T3 for the Treatment of Fibromyalgia

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sean Mackey, Stanford University

ClinicalTrials.gov Identifier:

NCT00903877

First received: May 15, 2009

Last updated: June 21, 2012

Last verified: June 2012

History of Changes

Purpose

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	Intervention
Fibromyalgia	Drug: T3 Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Participant, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Liothyronine sodium Liothyronine

U.S. FDA Resources

Further study details as provided by Sean Mackey, Stanford University:

Primary Outcome Measures:

Visual analogue scale of pain intensity [ Time Frame: Duration of the trial ]


Enrollment:	51
Study Start Date:	May 2009
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: T3	Drug: T3 Patients receive T3 in a dose of 25mcg and 50mcg
Placebo Comparator: Placebo - sugar pill	Drug: Placebo Patients receive a sugar pill

Eligibility


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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

new medication change in the last 2 months
any cardiac disease at all
known thyroid disease before or after thyroid screening bloodwork
unstable medical or psychiatric disease.
Known inflammatory or rheumatic disease other than fibromyalgia
substance abuse in the last year
suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
concomitant herbal medications
multiple severe medication allergies
the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
diabetes
smoking
Known uncontrolled hypertension
known uncontrolled hypercholesterolemia

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903877

Locations


United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Ian R Carroll	Stanford University

More Information


Responsible Party:	Sean Mackey, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT00903877 History of Changes
Other Study ID Numbers:	SU-04272009-2419 16295
Study First Received:	May 15, 2009
Last Updated:	June 21, 2012

Additional relevant MeSH terms:


Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases	Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on June 23, 2017

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